Status:
COMPLETED
Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells fou...
Detailed Description
OBJECTIVES: * Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen, gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified in incom...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage II-IV disease
- Completely resected disease
- No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
- HLA-A2 positive
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin \> 10 g/dL
- Platelet count ≥ 50,000/mm³
- AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled or current infection
- No known allergy to vaccine or immunoadjuvant components
- No known immune deficiency
- PRIOR CONCURRENT THERAPY:
- No chemotherapy within the past 4 weeks and recovered
- No biologic therapy within the past 4 weeks
- No radiation therapy within the past 4 weeks
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00470015
Start Date
March 1 2007
End Date
January 2 2013
Last Update
February 19 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905