A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

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