Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.


Study summary:

OBJECTIVES: - Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive. - Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201 negative. - Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment. - Evaluate the toxicity profiles of these regimens in these patients. OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization: - Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC. - Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients receive treatment as in group 1. - Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone. - All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization. Patients are followed at 3-4 weeks. PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven metastatic melanoma that has failed standard treatment - HLA-DRB1*0401 positive - Known HLA-A0201 status PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 90,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST or ALT less than 3 times normal - Hepatitis B surface antigen negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No symptomatic cardiac disease Immunologic: - No autoimmune disease - No primary or secondary immunodeficiency disease - HIV negative Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunization to the entire gp100 molecule - At least 3 weeks since prior gp100:209-217 antigen peptide - At least 3 weeks since other prior biologic therapy Chemotherapy: - At least 3 weeks since prior chemotherapy Endocrine therapy: - At least 3 weeks since prior endocrine therapy - No concurrent steroid therapy Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - Prior surgery for cancer allowed Other: - At least 3 weeks since any prior therapy except surgery for cancer


NCT ID:

NCT00019994


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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