Melanoma (Skin) Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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