Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Dacarbazine; Oblimersen

Criteria

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