Melanoma
Conditions
Keywords
Melanoma, Advanced Melanoma, Malignant Melanoma, Metastatic Melanoma, Skin Cancer, Genasense, oblimersen, antisense, Bcl-2 antisense, G3139, dacarbazine
Brief summary
This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
Interventions
DRUGdacarbazine plus Genasense
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
DRUGdacarbazine plus placebo
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
Sponsors
Genta Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of melanoma * Progressive disease that is not surgically resectable, or metastatic Stage IV * Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal * No prior chemotherapy * Measurable disease * ECOG performance status ≤ 1 * At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy * Prior immunotherapy allowed * Adequate organ function
Exclusion criteria
* Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment * Primary ocular or mucosal melanoma * Bone-only metastatic disease * History or presence of brain metastasis or leptomeningeal disease * Significant medical disease other than cancer * Organ allograft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival and overall survival | Every 42 days from date of randomization during protocol therapy |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, durable response rate, duration of response, safety | Response and progression every 42 days from date of randomization during protocol therapy |
Countries
Australia, Austria, Canada, Czechia, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed