CPG 7909 Injection in Melanoma

ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study

To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.

Inclusion Criteria:

• Histologically or cytologically confirmed melanoma that is metastatic.
• Measurable disease according to the RECIST criteria.
• Karnofsky Performance Status of > 70.

Exclusion Criteria:

• Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
• Suspected or known CNS metastases.