- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016263
Dacarbazine With or Without Oblimersen (G3139) in Treating Patients With Advanced Malignant Melanoma
Randomized Study Of Dacarbazine Versus Dacarbazine Plus G3139 (Bcl-2 Antisense Oligonucleotide) In Patients With Advanced Malignant Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen (G3139) may help dacarbazine kill more cancer cells by making tumor cells more sensitive to the drug. It is not yet known if dacarbazine is more effective with or without oblimersen (G3139).
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without oblimersen (G3139) in treating patients who have advanced malignant melanoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the survival of patients with advanced malignant melanoma treated with dacarbazine with or without oblimersen (G3139).
- Compare the response rate, durable response rate, and progression-free survival of patients treated with these regimens.
- Compare the safety of these regimens in this patient population.
- Compare the performance status, body weight, and tumor-related symptoms of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1 or 2), extent of metastases and lactate dehydrogenase (LDH) level (skin subcutaneous and/or lymph node metastases without visceral involvement and normal LDH vs any visceral metastases or elevated LDH), and liver metastases (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive dacarbazine IV over 60 minutes on day 1.
- Arm II: Patients receive oblimersen (G3139) IV continuously over days 1-6 followed by dacarbazine IV over 60 minutes on day 6.
Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial or complete response may be eligible for another 8 courses of treatment in an extension protocol.
Patients are followed at least every 2 months for up to 2 years after study.
PROJECTED ACCRUAL: A total of 750 patients (375 per arm) will be accrued for this study.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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New Jersey
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Berkeley Heights, New Jersey, United States, 07922
- Genta Incorporated
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
- Progressive disease that is unresectable or metastatic
- No primary ocular or mucosal melanoma
At least 1 unidimensionally measurable lesion by physical exam or imaging studies
- At least 10 mm by caliper for superficial cutaneous disease
- At least 20 mm by contrast-enhanced or spiral CT scan for visceral or nodal/soft tissue disease
- No bone metastases as only site of measurable disease
Lesions considered non-measurable include the following:
- Bone lesions
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging
- Lesions located in a previously irradiated area
- No brain metastases or leptomeningeal disease
- Considered a medical candidate for dacarbazine treatment
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL (hematopoietic growth factor or transfusion independent)
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Albumin at least 2.5 g/dL
- PT/PTT no greater than 1.5 times ULN
- No history of chronic hepatitis or cirrhosis
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No uncontrolled congestive heart failure
- No New York Heart Association class III or IV disease
- No symptomatic coronary artery disease (e.g., uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication)
- No cardiovascular signs and symptoms at least grade 2 within the past 4 weeks
Other:
- Intellectually, emotionally, and physically able to maintain an ambulatory infusion pump
- Satisfactory venous access
- No other significant medical disease
- No uncontrolled seizure disorder
- No active infection
- No uncontrolled diabetes mellitus
- No active autoimmune disease
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No known hypersensitivity to phosphorothioate-containing oligonucleotides or dacarbazine
- No known HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy, cytokine, biologic, or vaccine therapy in the adjuvant and/or metastatic setting and recovered
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF] or epoetin alfa) during course 1 of study
Chemotherapy:
- No prior cytotoxic chemotherapy, including regional perfusion
Endocrine therapy:
- No concurrent chronic corticosteroids with an average dose of at least 20 mg of prednisone or equivalent per day
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to measurable target lesions unless progression occurred at that site or measurable disease developed outside the treated area
Surgery:
- At least 4 weeks since prior surgery and recovered
- No prior organ allografts
Other:
- At least 3 weeks since prior experimental therapy
- No prior intratumoral injection therapy to measurable target lesions unless progression occurred at that site or measurable disease developed outside the treated area
- No concurrent immunosuppressive drugs
- No concurrent anticoagulation therapy except 1 mg/day of warfarin for central line prophylaxis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stanley R. Frankel, MD, Genta Incorporated
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Dacarbazine
- Oblimersen
Other Study ID Numbers
- CDR0000068616
- GENTA-GM301
- UCLA-0207109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
Clinical Trials on dacarbazine
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Genta IncorporatedCompletedMelanomaUnited States, France, United Kingdom, Spain, Switzerland, Australia, Canada, Germany, Poland, Italy, Austria, Czech Republic
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VicalCompletedRecurrent Melanoma | Stage IV Melanoma | Stage III MelanomaUnited States
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Cellxpert Biotechnology Corp.Medigen Biotechnology CorporationCompletedMelanomaAustralia, United States
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Simcere Pharmaceutical Co., LtdUnknownAdvanced Melanoma | Untreated PatientsChina
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H. Lee Moffitt Cancer Center and Research InstituteBristol-Myers SquibbCompleted
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National Cancer Institute (NCI)CompletedMelanoma (Skin)United States
-
Philogen S.p.A.Eudax S.r.l.TerminatedMetastatic MelanomaSwitzerland, Italy, Austria, Germany
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University of Erlangen-Nürnberg Medical SchoolWuerzburg University Hospital; University Hospital RegensburgRecruiting
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Virginia Commonwealth UniversityCompletedMelanoma | Soft Tissue Sarcoma | Parathyroid Carcinoma | Small Cell Carcinoma of the Lung | Carcinoid TumorsUnited States
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sigma-tau i.f.r. S.p.A.CompletedMalignant MelanomaFrance, Germany, Hungary, Italy, Poland, Portugal, Spain, Switzerland