Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT00518895
- Lead Sponsor
- Genta Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A dacarbazine plus Genasense Dacarbazine with Genasense B dacarbazine plus placebo Dacarbazine with placebo
- Primary Outcome Measures
Name Time Method Progression-free survival and overall survival Every 42 days from date of randomization during protocol therapy
- Secondary Outcome Measures
Name Time Method Response rate, durable response rate, duration of response, safety Response and progression every 42 days from date of randomization during protocol therapy
Trial Locations
- Locations (76)
University of South Alabama Hospital, Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
San Diego Pacific Oncology and Hematology Associates Inc.
🇺🇸Encinitas, California, United States
Redwood Regional Medical Group, Inc.
🇺🇸Santa Rosa, California, United States
Siouxland Hematology Oncology Associates
🇺🇸Sioux City, Iowa, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hematology Oncology Centers of the Northern Rockies
🇺🇸Billings, Montana, United States
Morristown Memorial - Atlantic Healthcare System
🇺🇸Morristown, New Jersey, United States
Cancer Care Associates
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates, Site 1
🇺🇸Tulsa, Oklahoma, United States
St. Luke's Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Scroll for more (66 remaining)University of South Alabama Hospital, Mitchell Cancer Institute🇺🇸Mobile, Alabama, United States