In-active trials are complete and no longer enrolling. Trials are listed in alphabetical order.
A
Anemia
Title: An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin alfa) for the Treatment of Anemia or Chronic Kidney Disease in the Long Term Care Setting. (EPOCKD2002)
Purpose: To demonstrate that PROCRIT in extended dosing intervals (every 2 weeks followed by every 4 weeks dosing) is safe and effective for the treatment of anemia in subjects with chronic kidney disease who reside in long term care facilities.
Principal Investigator: Levy, Susan
Phase: III
Approved Enrollment Number: 20
Current Enrollment: 0
Atherosclerosis
Title: A Single Center, Randomized, Open Label, Parallel Group Pharmacodynamic Study of a Novel Combination Form of Aspirin and Phytosterol versus Aspirin in Healthy Adult Subjects. (Bayer 13144)
Purpose: To determine if administration of the phytosterols 400 mg twice a day when taken as a combination tablet with aspirin effects the antiplatelet effects of aspirin vs. aspirin alone, as measured by serum thromboxane levels. To compare the effects of administration of phytosterols 400 mg twice a day in a combination tablet with aspirin and aspirin alone on platelet aggregation in response to arachidonic acid and collagen using LTA.
Principal Investigator: Gurbel, Paul A.
Phase: I
Approved Enrollment Number: 32
Current Enrollment: 30
B
Bladder Cancer
Title: A Phase II Study of Doxorubicin/Taxotere (DT) Followed by Gemcitabine/Cisplatin (GS) in Patients with Locally Advanced/Metastatic Cancer of the Bladder/Urothelium. (GCC 0318)
Purpose: To determine whether an investigational combination of chemotherapy drugs is capable of having an effect on the growth of bladder/urothelium cancer.
Principal Investigator: Hussain, Arif
Phase: II
Approved Enrollment Number: 12
Current Enrollment: 0
Bone Graft
Title: Reamer Irrigation Aspirator (RIA) Effluent Evaluation.
Purpose: To see if growth factors can be captured (specifically BMP-2) from RIA effluent using a Synthes proprietary technology.
Principal Investigator: Conway, Janet D.
Phase: I
Approved Enrollment Number: 10
Current Enrollment: 9
Breast Cancer
Title :A Phase 3 Study of SU011248 in Combination with Paclitaxel Versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer. (A6181094)
Purpose: To compare the progression-free survival (PFS) for patients having locally recurrent or metastatic breast cancer who receives SU011248 plus Paclitaxel versus bevacizumab plus Paclitaxel. To compare the safety of SU011248 plus Paclitaxel versus bevacizumab plus Paclitaxel in this patient population. To compare measures of duration of tumor control and overall survival. To assess patient reported outcomes. To explore the relationship between specific biomarkers and cancer- and treatment-related outcomes.
Principal Investigator: Truica, Cristina
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 2
Breast Cancer
Title: IXTEND: A Randomized Phase 2 Study to Evaluate the Combinations of Ixabepilone plus Capecitabine or Capecitabine plus Docetaxel in the Treatment of Metastatic Breast Cancer. (CA163131)
Purpose: To assess the response rate of subjects with metastatic breast cancer to treatment with ixabepilone plus capecitabine, and to investigate the response rate of subjects with metastatic breast cancer to treatment with docetaxel plus capecitabine. To investigate the response rates in triple-negative (TN) subjects and non-triple (NTN) subjects treated with ixabepilone plus capecitabine or docetaxel plus capecitabine. To evaluate the safety and toxicity profiles of the treatment regimens (ixabepilone plus capecitabine or docetaxel plus capecitabine). To evaluate the efficacy profiles, including time to progression, duration of response, and disease control rate.
Principal Investigator: Truica, Cristina
Phase: II
Approved Enrollment Number: 6
Current Enrollment: 1
Breast Cancer
Title: A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High Risk Node-Negative Breast Cancer. (EPP E1199/SWOG E1199)
Purpose: To compare different chemotherapy drugs in terms of side effects, survival, and disease-free survival and to determine whether weekly administration of taxane chemotherapy drugs improves disease-free survival and overall survival when compared to the conventional schedule.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number:
Current Enrollment:1
Breast Cancer
Title: Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients with Metastatic Breast Cancer. (SO430)
Purpose: To evaluate the response rate benefit (complete or partial response) progression-free and overall survival in women with metastatic breast cancer treated with simple oral combination therapy with cyclophosphamide and capecitabine. To assess the adverse events associated with this regimen.
Principal Investigator: Truica, Cristina
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 1
Breast or Lung Cancer
Title: A Phase 2, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer. (SNX-1012-CLN2-006)
Purpose: To decide the most effective dose of SNX-1012 that would shorten the length of time that subjects have oral mucositis. Also to evaluate how safe and how well-tolerated SNX-1012 is in subjects who have oral mucositis.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
C
Colon Cancer
Title: Prospective Randomized Clinical Trial on the Effect of Abound on Wound Healing in Surgical Patients.
Purpose: To study whether the post-operative administration of Abound (Abbott Nutrition) to patients undergoing colonic resection with primary anastomosis increases wound healing.
Principal Investigator: Barbul, Adrian
Phase: I
Approved Enrollment Number: 60
Current Enrollment: 0
Colorectal Cancer
Title: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab with and without Panitumumab in the First-Line Treatment of Subjects with Metastatic Colorectal Cancer. (Amgen 20040249)
Purpose: To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 4
Coronary Heart Disease
Title: Demonstration of the Pharmacodynamic Antiplatelet Effect of PRT060128 in Patients with High Platelet Reactivity During Clopidogrel and Aspirin Maintenance Therapy.
Purpose: This study is being carried out to see how well an investigational drug, PRT061028, given in addition to Clopidogrel and aspirin, works on preventing blood clots in patients who do not respond adequately to Clopidogrel or those patients who have a higher rate of clot formation.
Principal Investigator: Gurbel, Paul A.
Phase: I
Approved Enrollment Number: 45
Current Enrollment: 20
Coronary Heart Disease
Title: A Randomized Double-Blind, Double-Dummy, Parallel Group Study of the Onset and Offset of the Antiplatelet Effects of AZD6140 Compared with Clopidogrel and Placebo with Aspirin as Background Therapy in Patients with Stable Coronary Artery Disease and Additional Detailed Assessment of Cardiopulmonary Function. (D5130C00048)
Purpose: The primary objective of this study is to compare an experimental drug call AZD 6140 to Clopidogrel for treatment in the prevention of clot formation in people who have had acute coronary syndrome (ACS) and/or subjects who receive cardiac stents. Currently, the only available medication for those two indications is Clopidogrel (Plavix). However, it has been observed that not all subjects respond to treatment with Clopidogrel (Plavix) and some people still may form a clot while taking it. If approved, AZD 6140 will be an alternative drug in place of Clopidogrel (Plavix).
Principal Investigator: Gurbel, Paul A.
Phase: II
Approved Enrollment Number: 75
Current Enrollment: 43
Coronary Heart Disease
Title: A Randomized, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of AZD6140 Compared with Clopidogrel in Patients with Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-responders or Responders. [RESPOND]
Purpose: The primary objective of this study is to compare an experimental drug called AZD 6140 to Clopidogrel for treatment in the prevention of clot formation in people who have had acute coronary syndrome (ACS) and/or subjects who receive cardiac stents. Currently, the only available medication for those two indications is Clopidogrel (Plavix®). However, it has been observed that not all subjects respond to treatment with Clopidogrel (Plavix®) and some people still may form a clot while taking it. Patients, who are known to have very little effect on their platelets by clopidogrel (Plavix®) (non-responder), will be studied as well as patients who seem to have a typical response to clopidogrel (Plavix®) (responder). If approved, AZD 6140 will be an alternative drug in place of Clopidogrel (Plavix®). AZD6140 has been administered to 11,000 patients in clinical studies and is only available to patients enrolled in such clinical studies.
Principal Investigator: Gurbel, Paul A.
Phase: II
Approved Enrollment Number: 80
Current Enrollment: 42
Coronary Intervention
Title: A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12-Receptor Inhibitor, vs. Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent Percutaneous Coronary Interventions (INNOVATE-PCI)
Purpose: To help find out if a new investigational drug called PRT060128 is safe and effective for use in patients having a non-urgent PCI. A PCI is a procedure that is done to clear blockages in the blood vessels of your heart.
Principal Investigator: Gurbel, Paul A.
Phase: II
Approved Enrollment Number: 50
Current Enrollment: 27
Coronary Stent
Title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS ElementTM) for the Treatment of Up to Two De Novo Coronary Artery Lesions
Purpose: To compare the safety and effectiveness of two drug-eluting stents (a stent is an expandable metal tube that helps to hold the artery open so that blood can continue to flow through the artery) in the treatment of coronary artery disease: the PROMUS Element Everolimus-Eluting Coronary Stent System and the PROMUSTM Everolimus Eluting Coronary Stent System. The PROMUS Element and PROMUS stents are both coated with the same drug, everolimus. However, the two stents are made of different metals and are designed differently.
Principal Investigator: Gurbel, Paul A.
Phase: III
Approved Enrollment Number: 30
Current Enrollment:0
D
Degenerative Joint Disease
Title: A Phase I Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients with Degenerative Joint Disease Prior to Total Knee Arthroplasty. (TGC-03-01)
Purpose: To investigate the safety and bioavailability of TissueGene-C administered intra-articularly (IA) to patients with Degenerative Joint Disease, once over a four (4) week period prior to their scheduled total knee arthroplasty.
Principal Investigator: Mont, Michael A.
Phase: I
Approved Enrollment Number: 12
Current Enrollment: 6
Diabetes Mellitus
Title: An 8-Week, Randomized, Double-Blind, Parallel-Group, Multi-Center, Active-Controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients with Stage 2 Systolic Hypertension and Diabetes Mellitus.
Purpose: To demonstrate the BP lowering effect of aliskiren HCTZ (300/25 mg) combination versus amlodipine (10 mg) on mean sitting systolic blood pressure (msSBP) in patients with both stage 2 systolic hypertension and diabetes mellitus by non-inferiority testing, followed by superiority testing after 8 weeks of treatment.
Principal Investigator: Ravi, Chaitanya Kumar
Phase: IV
Approved Enrollment Number: 5
Current Enrollment: 3
Diabetic Foot Ulcers
Title: A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers. (KC-002)
Purpose: To determine the safety and effectiveness of the device, KC-002 interactive wound dressing, in the promotion of healing diabetic foot ulcers compared with conventional wound therapy regime for subjects with Type 1 or Type II diabetes mellitus.
Principal Investigator: Barbul, Adrian
Phase: II
Approved Enrollment Number: 30
Current Enrollment: 20
Diabetic Foot Ulcers
Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Diabetic Foot Ulcers. (VGF3554g)
Purpose: To evaluate the efficacy of daily treatment with topical telbermin (three different concentrations) versus placebo in healing diabetic foot ulcers. To evaluate the safety and tolerability of telbermin daily treatment for 12 weeks. To evaluate the pharmacokinetic properties of topical telbermin as measured by systemic concentration levels of vascular endothelial growth factor (VEGF) in subjects at various timepoints.
Principal Investigator: Barbul, Adrian
Phase: II
Approved Enrollment Number: 10
Current Enrollment: 3
E
Epithelial Ovarian & Primary Peritoneal Carcinomas
Title: A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy. (Biogen 206OC202)
Purpose: To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
Principal Investigator: Abbas, Fouad M.
Phase: I/II
Approved Enrollment Number: 3
Current Enrollment: 2
Euvolemic Hyponatremia
Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia (The HARMONY Study).
Purpose: To find out if lixivaptan, an investigational medication, can be used to decrease the amount of extra water in the body and to obtain additional information about the safety and effectiveness of lixivapatan.
Principal Investigator: Rajani, Sunil
Phase: III
Approved Enrollment Number: 4
Current Enrollment: 0
Euvolemic Hyponatremia
Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia (The HARMONY Study).
Purpose: To find out if lixivaptan, an investigational medication, can be used to decrease the amount of extra water in the body and to obtain additional information about the safety and effectiveness of lixivapatan.
Principal Investigator: Krug, Esther
Phase: III
Approved Enrollment Number: 4
Current Enrollment: 0
Ewing Sarcoma
Title: COG AEWS0521: A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND#7921) combined with Vincristine, Topotecan and Cyclophosphamide in Patients with Recurrent Ewing Sarcoma.
Purpose: To determine the feasibility of administering bevacizumab in combination with vincristine, topotecan, and cyclophosphamide (VTC) to patients with first recurrent Ewing Sarcoma (EWS). To estimate the progression free survival with vincristine, topotecan, cyclophosphamide with bevacizumab (VTC/bevacizumab in patients with first recurrent Ewing Sarcoma. To estimate the response rate to 2 cycles of VTC compared to 2 cycles of VTC/bevacizumab. To evaluate biological markers as related to prognosis and specifically related to angiogenesis by encouraging concurrent enrollment on the Ewing Sarcoma banking studies (AEWS02B@ and/or AEWS07B1), and ancillary correlative endothelial cell, surrogate marker and angiogenic gene studies.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
Ewing Sarcoma
Title: COG AEWS0621: Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults with Recurrent or Refractory Ewing Sarcoma.
Purpose: To estimate the response rate to cytarabine in children and young adults with relapsed or refractory Ewing sarcoma. To evaluate, in a preliminary fashion, the use of Ewing specific transcripts detected in peripheral blood as a surrogate marker for disease response. To evaluate, in a preliminary fashion, whether gene expression profiles of Ewing sarcoma tissue samples at diagnosis predict response to cytarabine.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
F
Follicular Lymphoma
Title: CO5011: A Phase 2 Study of VELCADE (bortezomib) in Combination with Bendamustine and Rituximab in Subjects with Relapsed or Refractory Follicular Lymphoma.
Purpose: To determine the maximum tolerated dose (MTD) of bendamustine in combination with bendamustine and rituximab provides benefit to subjects with relapsed or refractory follicular lymphoma as assessed by complete response (CR) per the revised International Working Group (IWG) criteria. To determine the maximum tolerated dose (MTD) of bendamustine in combination with VELCADE and rituximab, up to a maximum bendamustine dose of 90mg/m2. To evaluate the safety and tolerability of VELCADE in combination with bendamustine and rituximab. To determine the overall response rate (ORR: CR + partial response [PR]). To determine progression free survival (PFS). To determine duration of response (DOR).
Principal Investigator: Noga, Stephe>
Phase: II
Approved Enrollment Number: 6
Current Enrollment: 1
Follicular Non-Hodgkin's Lymphoma
Title: A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma. (114-NH-301)
Purpose: To compare the clinical benefit of galiximab and rituximab versus rituximab alone in patients with relapsed or refractory non-hodgkin's lymphoma. To determine the safety of galiximab when given in combination with rituximab. This will include looking at what side effects occur and how often they occur. Determine how galiximab and rituximab are broken down and eliminated by the body.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 1
Follicular Non-Hodgkin's Lymphoma
Title: A Randomized, Open-Label, Multicenter Study of Velcade with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory Rituximab Naïve or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma. (26866138-LYM-3001)
Purpose: To learn whether VELCADE when given with rituximab as a combination treatment is better than rituximab alone in treating patients with lymphoma. The primary comparison is to find out the difference of whether the condition responds to the study medication and if it does, how long the condition remains stable or continues to respond to the study medication.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 1
Fungal Infection
Title: An Open-Label, Intravenous to Oral Switch, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Immunocompromised Children Aged 2 to <12 Years Who Are At High Risk For Systemic Fungal Infection. (A1501088)
Purpose: To find out how the body uses the anti-fungal medicine called voriconazole when it is given intravenously and then switched to be given by mouth in children aged 2 to 12 years who are at high risk for systemic fungal infection. To find out what are the effects, good and/or bad, or giving voriconazole intravenously and then switching to oral (by mouth). To find out if there are any factors such as age, body weight, and genetic factors that affect the way the body uses voriconazole.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 1
G
H
High-Risk Melanoma
Title: Phase III Trial of High Dose Interferon Alpha-2b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma. (SWOG 0008)
Purpose: To compare overall survival and disease-free survival between patients with high-risk melanoma who receive high-dose interferon alpha-2B versus cisplatin, vinblastine, DTIC plus IL-2 and interferon. Also, to evaluate the toxicities of these two regimens in this patient population.
Principal Investigator: Didolkar, Mukund S.
Phase: III
Approved Enrollment Number:
Current Enrollment: 0
Hodgkin's Disease
Title: A Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low Risk Hodgkin Disease. (COG AHOD0431)
Purpose: To investigate the paradigm of response-based therapy for low risk Hodgkin disease by eliminating involved-field radiation therapy (IFRT) for subjects who achieve a CR with initial chemotherapy. To investigate whether three cycles of AV-PC for the treatment of low risk Hodgkin disease is sufficient to induce CR in at least 80% of subjects. To investigate whether subjects who experience a low risk relapse after initial treatment with chemotherapy alone can be successfully treated with a salvage regimen consisting of IV/DECA and IFRT. To maintain the overall survival (OS) for subjects with low risk Hodgkin disease at or above 97%. To determine the prognostic significance of very early response as measured by FDG-PET or gallium after the first course of chemotherapy. To evaluate the prognostic significance of elevation of ESR and CRP at the time of diagnosis in low risk Hodgkin disease on CR rate and relapse rate after chemotherapy alone. To determine the frequency and severity of late effects of therapy including thyroid dysfunction, infertility, cardiotoxicity and second malignant neoplasms.
Principal Investigator: Wiley, Joseph M.
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
I
Indolent Non-Hodgkin's Lymphoma
Title: Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Low Tumor Burden Patients with Indolent Non-Hodgkin's Lymphoma. (CTSU/E4402)
Purpose: To establish whether single doses of rituximab given at 12-week intervals can prolong disease control compared to giving rituximab once a week for four consecutive weeks at time of disease progression.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
J
Joint Disease
Title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease. (R331333-PAI-3002)
Purpose: To determine the efficacy of CG5503 immediate-release (IR) using the sum of pain intensity difference (SPID) over 5 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis.
Principal Investigator: Mont, Michael A.
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
K
L
Lung Cancer
Title: A Multi-center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax (L-BLP25 or BLP25 liposome vaccine) in Non-Small Cell Lung Cancer (NSCLC) Subjects with Unresectable Stage III Disease. (EMR 63325-001)
Purpose: Primary objective is to compare survival duration of all randomized subjects by treatment arm. Secondary objectives of this trial are to compare all randomized subjects by treatment arm for time to symptom progression (TTSP) as measured by the Lund Cancer Symptom Scale (LCSS); time to progression (TTP) as determined by the investigator; one, two and three year survival; and safety.
Principal Investigator: Erlich, Rodrigo
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
Lymphoma
Title: A Phase III, Open-Label, Prospective, Two-armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment with the Zevalin (ibritumomab tiuxetan) Study Regimen Versus Observation in Patients with Diffuse Large B-cell Lymphoma Who are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy. (307940/106-20)
Purpose: Evaluation of efficacy and safety of Zevalin, as well as assessment of quality of life.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
Lymphoma/Leukemia
Title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid) in Combination with Dexamethasone in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (CC-5013-NHL-005)
Purpose: To determine the efficacy of lenalidomide in combination with dexamethasone in relapsed or refractory diffuse large B-cell lymphoma. To evaluate the safety of lenalidomide in combination with dexamethasone as treatment for subjects with relapsed or refractory diffuse large B-cell lymphoma.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 4
Current Enrollment: 0
Lymphoma/Leukemia
Title: An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects with Lymphoma. (Amgen 20050144)
Purpose: To identify a safety dose and schedule of AMG 531 that is appropriate for treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy. To evaluate the overall efficacy of AMG 531 in subjects with severe thrombocytopenia due to multi-cycle chemotherapy.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 3
Current Enrollment: 0
M
Melanoma
Title: A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine with Placebo. (CA 184024)
Purpose: To examine the safety and effectiveness of two different treatments for patients with melanoma.
Principal Investigator: Didolkar, Mukund S.
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
Melanoma
Title: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma. (ECOG E2603)
Purpose: To compare the overall survival, progression-free survival, response rate, and safety of patients with stages 3 or 4 melanoma by randomizing them into two groups.
Principal Investigator: Didolkar, Mukund S.
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 1
Melanoma
Title: A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With 'No Evidence of Disease' after Complete Surgical Resection of 'Locally Advanced' and/or Stage IV Melanoma. (SWOG E4697)
Purpose: To compare overall survival, two-year survival, and time to progression of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with GM-CSF vs. no GM-CSF, or other high risk patients listed in the eligibility section.
Principal Investigator: Didolkar, Mukund S.
Phase: III
Approved Enrollment Number: 2
Current Enrollment: 2
Myeloma
Title: A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination with Bortezomib in Patients with Relapsed or Refractory Multiple Myeloma. (AVF4064g)
Purpose: To make a preliminary assessment of the efficacy of combining bevacizumab with bortezomib relative to bortezomib with placebo in patients with relapsed or refractory multiple myeloma, as measured by progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria, as assessed by the investigator. To evaluate the safety and tolerability of combining bevacizumab with bortezomib relative to bortezomib with placebo in patients with relapsed or refractory multiple myeloma. To make a preliminary assessment of the efficacy of combining bevacizumab with bortezomib relative to bortezomib with placebo, as measured by overall response, duration of response, and overall survival in patients with relapsed or refractory multiple myeloma. Overall response and duration of overall response will be based on investigator assessment using the IMWG Uniform Response Criteria.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 10
Current Enrollment: 2
N
Nausea
Title: NKV110721, A Study of Single Dose Intravenous Casopitant in Combination with Ondansetron and Dexamethasone for the Prevention of Oxaliplatin-Induced Nausea and Vomiting
Purpose: To demonstrate the superiority of triple therapy, single-dose 90 mg IV casopitant in combination with ondansetron and dexamethasone, over dual therapy ondansetron and dexamethasone for the prevent of emesis over the first 0-120 hours(overall phase) following initiation of the first cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the prevention of emesis over the acute (0-24 hours) and delayed (24-120 hours) phases following initiation of the first cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the prevention of emesis over the overall (0-120 hours) phase following the second cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the control of nausea over the overall, acute and delayed phases following initiation of the first cycle of oxaliplatin-based MEC. Quantify the impact of the prophylactic anti-emetic regimens on daily life activities, as assessed by the FLIE questionnaire during the first cycle of oxaliplatin-based MEC. Evaluate the PK of single-dose 90mg IV casopitant and metabolites in a sub-set of subjects when administered in combination with ondansetron hydrochloride and dexamethasone during the first cycle of oxaliplatin-based MEC. Determine the safety and tolerability of single-dose 90 mg IV casopitant when administered as part of the antiemetic regimen outlined in this protocol.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
Neuroblastoma
Title: A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma. (COG ANBL0421)
Purpose :To find out whether neuroblastoma in children who have recurrent or refractory disease responds to treatment when the children are given the chemotherapy drugs irinotecan and temozolomide.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
Neuroblastoma
Title: A Phase II Study of hu14.18-IL2*(BB-IND-9798) in Children with Recurrent or Refractory Neuroblastoma. (COG ANBL0322)
Purpose: To determine the response rate, adverse events, and immunologic activation induced by hu14.18-IL2* in children with recurrent/refractory neuroblastoma.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
Non-Small Cell Lung Cancer
Title: A Randomized Phase 2 Trial of Erlotinib With or Without PF-3512676 for the Treatment of Patients with Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy Regimen. (A8501006)
Purpose: To assess Progression Free Survival (PFS) in patients randomized to PF-3512676 in combination with erlotinib (Investigational Treatment Arm) and PFS in patients randomized to erlotinib alone (Control Treatment Arm). To assess secondary measurements of efficacy for PF-3512676 in combination with erlotinib. To assess the safety and tolerability of PF-3512676 in combination with erlotinib. To assess the effect of PF-3512676 on the steady-state plasma trough concentration of erlotinib. To assess the effect of PF-3512676 in combination with erlotinib on selected biomarkers of immune activation. To evaluate EGFR expression gene amplification and genotype in NSCLC tumor tissue. To determine germline TLR-9 and EGFR genotypes, and to explore the association between genotype and measures of efficacy, safety and immune activation.
Principal Investigator: Erlich, Rodrigo
Phase: II
Approved Enrollment Number: 10
Current Enrollment: 0
Non-Small Cell Lung Cancer
Title: A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced Non-squamous Non-Small Cell Lung Cancer. (Amgen 20060136)
Purpose: To estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arms A and B) and the paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC. To estimate the duration of response, progression-free survival, and overall survival in each of the 3 treatment arms. To evaluate the safety and tolerability in the 3 treatment arms. To evaluate the pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B.
Principal Investigator: ;Erlich, Rodrigo
Phase: II
Approved Enrollment Number: 2
Current Enrollment: 0
Non-Small Cell Lung Cancer
Title: PR104-2003: A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer.
Purpose: To determine if Doxetaxel is more effective when given alone or when Doxetaxel is given with PR104.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 8
Current Enrollment: 0
Non-Small Cell Lung Cancer
Title: MAGRIT 109493: A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of reMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients with Resectable MAGE-3-Positive Non-Small Cell Lung Cancer.
Purpose: To demonstrate the clinical efficacy of reMAGE-A3 + AS15 versus placebo in NSCLC after complete surgical resection. Two co-primary objectives are efficacy in the overall population and efficacy in the population of patients who did not receive adjuvant chemotherapy (no-CT population).
Principal Investigator: Erlich, Rodrigo
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
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Osteonecrosis
Title: Multi-center Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis of the Femoral Head. (Protocol ABI-55-0705-1 Rev 01)
Purpose: To evaluate the use of tissue repair cells to prevent the progression of osteonecrosis of the hip. Tissue repair cells are the patient's own bone marrow cells, removed from the patient's pelvic bone, grown and processed in a nutrient-rich solution, and mixed with bone proteins and blood proteins.
Principal Investigator: Mont, Michael A.
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 7
Osteosarcoma
Title: A Phase II Study of Aerosolized GM-CSF (NSC #613795, IND# 11042) in Patients with First Pulmonary Recurrence of Osteosarcoma (COG AOST0221).
Purpose: To find out the effects, good and bad, of inhaling GM-CSF, and find out whether inhaling GM-CSF will stimulate the body's natural line of defence (the immune system, specifically in this study the macrophages, dendritic cells, and membrane receptors) to destroy the osteosaroma lung tumors.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 2
Current Enrollment: 0
Occluded Central Venous Access Devices
Title: Phase 3, Multicenter, Multi-National, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects with Occluded Central Venous Access Devices. (HA008)
Purpose: To evaluate the safety of Alfimeprase as assessed by monitoring of adverse events. To evaluate the efficacy of Alfimeprase as measured by the restoration of the catheter flow at various time points: 15 and 30 minutes after initial drug administration, and 30 minutes after the administration of one or two doses of the study drug.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
Ovarian Cancer
Title :A Phase II Single Arm Study of Carboplatin and DOXIL Plus Bevacizumab in Subjects with Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers. (DOXILOVC2007)
Purpose: To establish which dose of DOXIL plus Carboplatin and Bevacizumab (AVASTIN) can be given safely to patients and obtain the desired result in order to determine the effectiveness of the combination in treating ovarian, fallopian tube, or peritoneal cancer that has reoccurred.
Principal Investigator: Abbas, Fouad M.
Phase: II
Approved Enrollment Number: 6
Current Enrollment: 0
Ovarian Cancer
Title: Phase II Evaluation of Weekly Hycamtin in Recurrent Platinum-Sensitive and Platinum-Resistant/Refractory Ovarian Cancer.
Purpose: To evaluate a 30-minute infusion of Hycamtin given on a weekly basis for 6 weeks in a row, followed by 2 weeks off.
Principal Investigator: Abbas, Fouad M.
Phase: II
Approved Enrollment Number: 10
Current Enrollment: 0
Ovarian Cancer
Title: Phase 3 Randomized Study of TLK286 Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer. (TLK286.3017)
Purpose: To learn whether TLK286 is better than standard therapy in prolonging the life of patients with recurrent ovarian cancer. Also, to compare the effects on tumor growth and the safety of the different study treatments.
Principal Investigator: Abbas, Fouad M.
Phase: III
Approved Enrollment Number:
Current Enrollment: 2
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Pain
Title: An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study of Repeat-Doses of DIC075V (Intravenous Diclofenac Sodium) in Patients with Acute Post-Operative Pain. (DFC-010)
Purpose: To evaluate the safety of DIC075V (Diclofenac Sodium) an injectable non-steroidal drug (NSAID) under investigation as a 37.5mg/ml injection to alleviate post operative pain following multiple doses (minimum of 8 doses) over multiple days (maximum of 5 days).
Principal Investigator: Mont, Michael A.
Phase: III
Approved Enrollment Number: 30
Current Enrollment: 0
Palmer/Plantar Syndrome
Title: A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients with Metastatic Breast and Colorectal Cancer. (CCC-03-26)
Purpose: To determine the efficacy of celecoxib in reducing the incidence and severity of Hand/Foot syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 0
Platelet Function
Title: A Randomized, Open-Label, Cross-Over, Study to Evaluate the Inhibitory Effect of Clopidogrel Plus EC Aspirin (325 mg) and Clopidogrel Plus PA32540 on Platelet Aggregation in Healthy Volunteers.
Purpose: This study will examine the effects of aspirin, clopidogrel, and omeprazole on platelet functions.
Principal Investigator: Gurbel, Paul A.
Phase: I
Approved Enrollment Number: 30
Current Enrollment: 30
Pressure Ulcers
Title: Envision Surface Evaluation for Patients with Stage II, III or Stage IV Pressure Ulcers.
Purpose: To gather early clinical information for a new hospital mattress.
Principal Investigator: Papantonio, Cathie
Phase: I
Approved Enrollment Number: 40
Current Enrollment: 17
Prostate Cancer
Title: Phase I/II Study of Weekly Doxorubicin and Taxotere, Followed by Total Androgen Suppression (TAS) in Patients Who Experience Biochemical Failure after Prostatectomy and/or Radiation for Localized/Locally Advanced Prostate Cancer. (GCC 0162)
Purpose: To determine whether an investigational combination of chemotherapy drugs followed by hormone therapy can stop or slow down prostate cancer from growing.
Principal Investigator: Hussain, Arif
Phase: II
Approved Enrollment Number: 10
Current Enrollment: 0
Prostate Cancer
Title: Phase I/II Study of Weekly doxorubicin and Taxotere for the Treatment of Patients with Hormone Refractory Prostate Cancer. (GCC 9983)
Purpose: To determine efficacy and safety of a weekly regimen of doxorubicin and taxotere in which the doxorubicin dose remains fixed, while that of taxotere is modified in patients with HRPC with respect to toxicity and tolerability, PSA response, overall response with the above treamtent combiantion, and overall survival.
Principal Investigator: Hussain, Arif
Phase: II
Approved Enrollment Number: 12
Current Enrollment: 2
Prostate Cancer
Title: A Randomized Double-Blind Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone with and without Bevacizumab (IND #7921, NSC #704865) in Men with Hormone Refractory Prostate Cancer. (CALGB 90401)
Purpose: To compare the effects of the standard combination of the drugs docetaxel and prednisone with the combination of docetaxel, prednisone, and the experimental drug bevacizumab on subjects with prostate cancer.
Principal Investigator: VanderVelde, Nancy
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
Pulmonary Embolism
Title: An International, Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Study of 3-Month or 6-Month Treatment with SSR126517E (3.0 mg s.c. once weekly) Versus Oral INR-Adjusted Warfarin in the Treatment of Patients with Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Venous Thrombosis. (EFC6034)
Purpose: To compare the safety and effectiveness of biotinylated idraparinux with the standard treatment of pulmonary embolism. It will also assess the safety and effectiveness of avidin, which will act as an antidote for biotinylated idraparinux in case of major bleeding.
Principal Investigator: Ravi, Chaitanya Kumar
Phase: III
Approved Enrollment Number: 6
Current Enrollment: 0
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Rectal Cancer
Title: Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior To and Following Combined Prolonged Venous Infusion Plus Pelvis XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior To and Following Combined Pelvic XRT in Patients with Rectal Cancer, Phase III, Intergroup. (SWOG 9304)
Purpose: To investigate which of three methods of 5-FU administration (prior to and following radiation and chemotherapy), and whether the administration of other drugs (leucovorin and levamisole) plus 5-FU, produces the best cure rates. In addition, the side effects of 5-FU with or without leucovorin or levamisole along with radiation and chemotherapy will be evaluated.
Principal Investigator: Didolkar, Mukund S.
Phase: III
Approved Enrollment Number:
Current Enrollment: 1
Recurrent Malignancies
Title: COG ADVL0525: A Phase II Study of Pemetrexed in Children with Recurrent Malignancies.
Purpose: To estimate the response rate to pemetrexed administered intravenously every 21 days in children with relapsed or refractory osteosarcoma, Ewing sarcoma/peripheral PNET, rabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/surpratentorial PNET or non-brainstem high grade glioma. To further define and describe the toxicities of pemetrexed.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
Recurrent Solid Tumors
Title: Phase II Trial of Ixabepilone (BMS-247550), An Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors. (COG ADVL0524)
Purpose: To Determine the response rate to Ixabepilone in various strata of recurrent solid malignant tumors of childhood and young adults. The target tumors are embryonal or alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/Peripheral neuroectodermal tumor (PNET), synovial sarcoma or malignant peripheral nerve sheath tumor (MPNST), Wilm's tumor, and neuroblastoma. To determine the time to progression for each tuor strata. To prospectively evaluate the feasibility and utility of automated volumeteric tumor measurement in patients with measurable pulmonary metastases, and escriptively compare volumetric measurements to 1D (RECIST criteria) and 2D (WHO criteria) measurements. To further define and describe the toxicities of Ixabepilone.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
Refractory/Recurrent Hodgkin Disease
Title: A Phase II Study of Bortezomib (Velcade, PS-341, IND #58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease. (COG AHOD0521)
Purpose: To determine the efficacy and safety of bortezomib as a chemo-sensitizing agent in primary refractory HD or HD in first relapse. Respone rate to bortezomib with ifosfamide/vinorelbine (IVB) will be compared to the historical response rate using ifosfamide/vinorelbine (IV) alone. Primary response rate will be determined by complete response (CR) rate following two cycles of chemotherapy. The secondary objectives are to determine the overall response rate (CP+PR) after 2 and 4 cycles of therapy, induction success rate after 2 or 4 cycles of therapy, and the reinduction rate (CR) after 4 cycles of therapy and to determine the proportion of patients able to mobilize sufficient hematopoietic stem cells (CD34+) after 2 cycles of IVB.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
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Seizures
Title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/day Monotherapy in Subjects with Partial-onset Seizures. (SP902)
Purpose: To demonstrate the efficacy and safety of conversion to lacosamide 400 mg/day monotherapy for partial-onset seizures (with or without secondary generalization) in subjects 16 to 70 years of age who are withdrawn from 1 to 2 marketed antiepileptic drugs.
Principal Investigator: Sinha, Saurabh
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
Seizures
Title: A Multicenter, Open-Label Extension Trial to Assess the Long-Term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures. (SP904)
Purpose: To obtain information about the percentage of subjects who remain on lacosamide monotherapy, and the duration of lacosamide monotherapy treatment. To obtain information about the long-term safety of lacosamide when used as monotherapy or adjunctive therapy in subjects with partial-onset seizures.
Principal Investigator: Sinha, Saurabh
Phase: III
Approved Enrollment Number: 5
Current Enrollment: 0
Septic Shock
Title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock. (Protocol F1K-MC-EVDP)
Purpose: To determine if drotrecogin alfa (activated) treatment provides significant mortality reduction and organ function improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. Will assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock.
Principal Investigator: Barbul, Adrian
Phase: III
Approved Enrollment Number: 6
Current Enrollment: 0
Sickle Cell Anemia
Title: The IMPROVE Trial: Improving Pain Management and Outcomes with Various Strategies of Patient-Controlled Analgesia (PCA)
Purpose: To find out which two different treatment plans of Patient-Controlled Analgesia is more effective when used to treat people with Sickle Cell disease who is admitted to the hospital for a pain crisis.
Principal Investigator: Fixler, Jason M.
Phase: III
Approved Enrollment Number: 10
Current Enrollment: 2
Small Cell Lung Cancer
Title: A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients with Extensive Small Cell Lung cancer Sensitive to First-Line Chemotherapy. (CNF3140-SCLC-05004)
Purpose: To evaluate the effect of amrubicin compared to topotecan on lung cancer.
Principal Investigator: Noga, Stephen
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 2
Soft Tissue Sarcoma
Title: COG ADVL0221: A Phase II Study of Trabectedin (ET-743, Yondelis) in Children with Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomysarcomatous Soft Tissue Sarcomas.
Purpose: To estimate the response rate to trabectedin administered as 24 hour continuous infusion every 3 weeks in patients with recurrent or refractory rhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma and Ewing sarcoma family of tumors. To further assess the tolerability and toxicity of trabectedin in children with recurrent cancer. To further delineate the pharmacokinetics of trabectedin in children with recurrent cancer.
Principal Investigator: Wiley, Joseph M.
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 0
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Total Hip Arthroplasty
Title: Deep Vein Thrombosis Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy versus Low Molecular Weight Heparin. (R-QAP-04-01-01-001)
Purpose: To evaluate the safety and effectiveness of ActiveCare Continuous Enhanced Circulation Therapy (CECT) device with or without baby aspirin (81 mg aspirin daily) for lowering the potential risk of Deep Vein Thrombosis (blood clots) during and after Total Hip Arthroplasty (THA) in comparison with Low Molecular Weight Heparin (LMWH).
Principal Investigator: Mont, Michael A.
Phase: IV
Approved Enrollment Number: 100
Current Enrollment: 51
Total Hip Replacement
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty. (114-03P)
Purpose: To evaluate the postoperative analgesic effectiveness, safety and tolerability of a single intra-operative dose of the study drug 4975 in patients undergoing primary unilateral total hip replacement. The pharmacokinetic profile of 4975 will be studies as well.
Principal Investigator: Mont, Michael A.
Phase: II
Approved Enrollment Number: 20
Current Enrollment: 0
Total Hip Replacement
Title: A Randomized, Double-Blind, Active and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension. (R331333-PAI-3001)
Purpose: To evaluate if CG5503 is safe and effective in treating pain.
Principal Investigator: Mont, Michael A.
Phase: III
Approved Enrollment Number: 40
Current Enrollment: 5
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Ulcers
Title: A Randomized Controlled Study to Evaluate the Healing Rate of Stage III and Stage IV Ulcers Comparing the New Envision Surface with Flexicair Eclipse Mattress Surfaces. (Eclipse Mattress)
Purpose: To measure the rate of wound healing in pressure ulcers for a new hospital mattress called Envision and compare those rates to a surface called Flexicair Eclipse, that has been used widely to treat pressure sores.
Principal Investigator: Papantonio, Cathie
Phase: I
Approved Enrollment Number: 15
Current Enrollment: 0
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Venous Thromboembolism
Title: Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study
Purpose: This study is an extension of the Einstein VTE treatment study. This is being done to show that the incidence of recurrence of pulmonary embolism or deep vein thrombosis during an additional 6 or 12 months of treatment with rivaroxaban (BAY 59-7939) is lower when compared to 6 or 12 months of placebo and that the likely advantage of an extended effect is not offset by an increase of bleeding complications.
Principal Investigator: DiMarsico, Ledys
Phase: III
Approved Enrollment Number: 20
Current Enrollment: 1
Venous Thromboembolism
Title: EFC6521: A Multinational, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and who are Undergoing Chemotherapy.
Purpose: To compare the efficacy of once daily (q.d..) subcutaneous (s.c.) injections of 20 mg AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number: 9
Current Enrollment: 0
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