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 phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.


Study summary:

OBJECTIVES: - Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51. OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of melanoma - Unresectable stage III or IV disease - Mucosal or ocular disease allowed - Positive HLA-A1, -A2, or -A3 expression PATIENT CHARACTERISTICS: Age - 12 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 - Weight ≥ 100 pounds - Not pregnant or nursing - No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior vaccination with any of the peptides used in this protocol - More than 1 year since prior melanoma vaccine therapy - More than 4 weeks since prior immunotherapy - More than 4 weeks since prior growth factors - More than 4 weeks since prior allergy shots Chemotherapy - More than 4 weeks since prior chemotherapy Endocrine therapy - More than 4 weeks since prior steroid therapy Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - Prior tumor resection allowed


NCT ID:

NCT00089206


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: December 16, 2017

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