Expired Study
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Charlottesville, Virginia 22908


Purpose:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.


Study summary:

OBJECTIVES: - Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF). OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43. - Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. - Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine. PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of stage IIIB, IIIC, or IV melanoma - HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive - Brain metastases allowed at the discretion of the principle investigator PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count > 1,000/mm^3 - Platelet count > 100,000/mm ^3 - Hemoglobin > 9 g/dL Hepatic - Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease Other - Prior diagnosis of other cancer allowed - Not pregnant or nursing - Weight ≥ 110 pounds - No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior growth factors - More than 4 weeks since prior allergy shots - More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine - No prior vaccination with any of the peptides used in this study Chemotherapy - More than 4 weeks since prior chemotherapy Endocrine therapy - More than 4 weeks since prior steroids Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - Not specified Other - More than 1 month since prior investigational drugs or therapies - No other concurrent investigational drugs or therapies


NCT ID:

NCT00089219


Primary Contact:

Study Chair
Craig L. Slingluff, MD
University of Virginia


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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