Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00089219
Start Date
July 1 2003
Last Update
November 20 2014
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908