Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 stag...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00089206
Start Date
August 1 2002
Last Update
December 19 2014
Active Locations (1)
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1
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908