Dacarbazine With or Without Oblimersen (G3139) in Treating 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.
Biological: oblimersen sodium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Study Of Dacarbazine Versus Dacarbazine Plus G3139 (Bcl-2 Antisense Oligonucleotide) In Patients With Advanced Malignant Melanoma|
|Study Start Date:||July 2000|
|Study Completion Date:||December 2004|
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, New Jersey|
|Berkeley Heights, New Jersey, United States, 07922|
|Study Chair:||Stanley R. Frankel, MD||Genta Incorporated|