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
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Experimental
CTLA4-Blocking Monoclonal Antibody