Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines may make the body build an immune response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.


Study summary:

OBJECTIVES: Primary - Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206) administered with autologous dendritic cells pulsed with MART-1 antigen in patients with unresectable stage III or stage IV melanoma. - Determine the biological activity and immune effects of this regimen in these patients. Secondary - Correlate CTLA4 genotype with safety of this regimen and/or immune response in these patients. - Determine, preliminarily, the efficacy of this regimen, in terms of clinical benefit rate, in these patients. OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206). Patients receive CP-675,206 IV on days 0, 28, 60, and 90 and autologous dendritic cells pulsed with MART-1 antigen intradermally on days 0, 14, and 28. After day 120, patients with stable or responding disease may receive additional doses of CP-675,206 monthly in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CP-675,206 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-21 patients will be accrued for this study within 3-10 months.


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


NCT ID:

NCT00090896


Primary Contact:

Study Chair
Antoni Ribas, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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