Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Genta Incorporated
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
