Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.
Malignant Conjunctival Neoplasm
Biological: MART-1:27-35 peptide vaccine
Biological: gp100:209-217(210M) peptide vaccine
Biological: incomplete Freund's adjuvant
Biological: tyrosinase peptide
Drug: agatolimod sodium
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: immunologic technique
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma|
- Safety [ Designated as safety issue: Yes ]
- Immunologic response as measured by ELISPOT assays [ Designated as safety issue: No ]
- Breadth of the immune response as measured by the number of peptides to which the response is observed [ Designated as safety issue: No ]
- Depth of the immune response [ Designated as safety issue: No ]
- Objective tumor response (complete response and partial response) by RECIST criteria [ Designated as safety issue: No ]
- Anti-pigmentary response [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant in patients with unresectable recurrent stage III or IV melanoma.
- Determine the efficacy of immunoadjuvants CpG 7909 and GM-CSF, in terms of a strong antigen-specific CD8+ T-cell response, in these patients.
- Determine the anti-pigmentary response to this regimen in these patients.
- Determine the anti-tumor response, in terms of objective tumor regression, progression-free survival, and overall survival, in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant subcutaneously on days 1 and 15. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, day 50-53, and day 91-94. Samples are examined by ELISPOT assay to measure lymphocyte immune response and by flow cytometry for biomarker quantification and T-cell response.
After completion of study treatment, patients are followed up periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471471
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ahmad A. Tarhini, MD, MS||University of Pittsburgh|