Expired Study
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Los Angeles, California 90089


Purpose:

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.


Study summary:

OBJECTIVES: - Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo. - Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - Measurable disease after attempted curative surgery - Unresectable stage III or IV uveal melanoma - Metastatic mucosal melanoma - HLA-A2.1 positive - No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9.0 g/dL - No coagulation disorders Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months - Patients with documented or suspected coronary artery disease must undergo stress thallium test - No major cardiovascular illness Pulmonary: - No major pulmonary illness Immunologic: - HIV negative - Hepatitis B surface antigen negative - Hepatitis C antibody negative - No history of uveitis or autoimmune inflammatory eye disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No major systemic infection - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens Chemotherapy: - At least 1 month since prior chemotherapy for melanoma Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - At least 1 month since prior radiotherapy for melanoma Surgery: - See Disease Characteristics Other: - At least 1 month since prior adjuvant therapy for melanoma - At least 1 month since other prior therapy for melanoma


NCT ID:

NCT00006113


Primary Contact:

Study Chair
Jeffrey S. Weber, MD, PhD
University of Southern California


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90089
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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