Status:
COMPLETED
Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and...
Detailed Description
OBJECTIVES: * Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma. * Collect, preliminar...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Prior diagnosis of melanoma meeting the following criteria:
- Stage II-IV disease
- Complete resection of disease
- No current evidence of disease
- HLA-A2 positive
- No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 75,000/mm³
- AST ≤ 3 times upper limit of normal
- No uncontrolled or current infection
- No known allergy to vaccine or adjuvant components
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known immune deficiency
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior biologic therapy
- No concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00470379
Start Date
April 1 2006
End Date
October 1 2011
Last Update
October 31 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905