CPG 7909 Injection in Melanoma

• Drug: CPG 7909 Injection
  
  CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
  Other Name: ProMune, PF-3512676
• Drug: dacarbazine
  
  dacarbazine 850mg/m2 in three-week cycles until disease progression
  Other Name: DTIC
• Drug: Chemotherapy
  

  Chemotherapy in three-week cycles until disease progression:

  dacarbazine 850mg/m2

  Other Name: DTIC
• Drug: CPG 7909 Injection
  
  CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
  Other Name: ProMune, PF-03512676
• Drug: CPG 7909 Injection
  
  CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
  Other Name: ProMune, PF-03512676

• Experimental: CPG 7909 Injection plus chemotherapy
  
  CPG 7909 Injection plus DTIC
  Interventions:
  

  • Drug: CPG 7909 Injection
  • Drug: dacarbazine
• Active Comparator: Chemotherapy alone
  
  dacarbazine
  Intervention: Drug: Chemotherapy
• Experimental: CPG 7909 Injection 10 mg
  
  Intervention: Drug: CPG 7909 Injection
• Experimental: CPG 7909 Injection 40 mg
  
  Intervention: Drug: CPG 7909 Injection

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.