Expired Study
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Los Angeles, California 90089


Purpose:

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.


Study summary:

OBJECTIVES: - Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF). OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. - Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. - Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma - Resected or rendered disease-free - HLA-A2.1-positive by standard cytotoxicity assay - Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry - Must be positive for at least 1 antigen - Failed, ineligible for, or refused prior interferon alfa PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL - No bleeding disorder Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2.5 times normal - No coagulation disorder - Hepatitis surface antigen B negative - Hepatitis C negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No major cardiovascular illness Pulmonary: - No major respiratory illness Immunologic: - No prior uveitis - No prior autoimmune inflammatory eye disease - No immune hemolytic anemia - No other active autoimmune disease Other: - HIV negative - No major gastrointestinal illness - No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago - No major systemic infection (e.g., pneumonia or sepsis) - No other major medical illness - No prior allergic reaction to Montanide ISA-51 or alum adjuvant - No requirement for steroid therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides Chemotherapy: - At least 1 month since prior adjuvant chemotherapy for this disease - No concurrent adjuvant chemotherapy Endocrine therapy: - No concurrent steroids Radiotherapy: - At least 1 month since prior radiotherapy for this disease - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - At least 1 month since other prior therapy, including adjuvant therapy, for this disease - No other concurrent therapy, including adjuvant therapy


NCT ID:

NCT00031733


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: December 13, 2017

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