CP-675,206 (CTLA4-Blocking Monoclonal Antibody) Combined With Dendritic Cell Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery

Inclusion Criteria:

• Histologically confirmed cutaneous or mucosal melanoma, meeting criteria for 1 of the following:
• Unresectable stage III disease (locally relapsed unresectable, in-transit lesions, or unresectable draining nodes)

• Stage IV disease, metastatic to 1 of the following sites:

  • Skin, subcutaneous tissues, or distant lymph nodes
  • Lung
  • Other visceral sites with lactic dehydrogenase ≤ 2 times upper limit of normal (unless due to liver stasis)
• De novo metastatic disease allowed provided patient refused any standard or approved stage-appropriate therapy for melanoma
• Measurable disease
• HLA-A2.1 positive (HLA-A*0201 by molecular subtyping)
• MART-1-expressing tumor by reverse transcription polymerase chain reaction or immunohistochemistry
• No symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks
• Age 18 and over
• Performance status ECOG 0-1 OR
• Karnofsky 70-100%
• HIV negative
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• More than 30 days since prior immunotherapy for metastatic, relapsed, or primary melanoma
• More than 30 days since prior chemotherapy for metastatic, relapsed, or primary melanoma
• More than 4 weeks since prior corticosteroids
• More than 30 days since prior radiotherapy for metastatic, relapsed, or primary melanoma
• More than 30 days since prior surgery for metastatic, relapsed, or primary melanoma.
• More than 30 days since other prior therapy for metastatic, relapsed, or primary melanoma
• More than 14 days since prior anti-infective therapy
• More than 4 weeks since prior immune suppressive therapy (e.g., cyclosporine)

Exclusion Criteria:

• chronic hepatitis B or C
• asthma
• inflammatory bowel disease
• celiac disease
• history of chronic colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding
• active chronic inflammatory or autoimmune disease, including any of the following:
• Psoriasis
• Rheumatoid arthritis
• Multiple sclerosis
• Hashimoto's thyroiditis
• Addison's disease
• Graves' disease
• Systemic lupus erythematosus
• active infection OR fever over 100° F within the past 3 days
• allergy to study drugs
• pregnant
• symptomatic seizures
• other medical problem that would preclude study participation
• prior melanoma immunotherapy containing MART-1 antigen
• prior anti-T-cell therapy
• prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CP-675,206)
• organ allografts requiring long-term immune suppressive therapy