A Phase 1 interventional study of gp100:209-217(210M) Peptide Vaccine and HPV 16 E7:12-20 Peptide Vaccine in Recurrent Melanoma, Stage IA Skin Melanoma and Stage IB Skin Melanoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Prevention
This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PRIMARY OBJECTIVES:
I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered >= 12 months after the last immunization.
II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination >= 12 months after the last immunization.
III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination >= 12 months after the last immunization.
IV. To perform detailed studies of the memory T cells persisting >= 12 months after immunization.
OUTLINE:
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed up at 6 months, every 6 months for 5 years, and then annually thereafter.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 30 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Exclusion Criteria:
Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 SC on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.
Biological: gp100:209-217(210M) Peptide Vaccine · Biological: HPV 16 E7:12-20 Peptide Vaccine · Other: Laboratory Biomarker Analysis
Given SC
Given SC
Also known as: HPV-16 E7(12-20) peptide, HPV-16E7(12-20) peptide vaccine, HPV16 E7(12-20) peptide, HPV16 E7(12-20) peptide vaccine
Correlative studies
Percentage of positive CD8+ T cells
Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.
Time frame: Up to 11 years
Change in CD8+ T cell frequency
Differences in immune parameters will be graphically depicted by means of density plots, frequency histograms, box and whisker-plots, dot-plots, trellis graphics (where appropriate) and other plots and graphs. Analyses of continuous variables will be performed first on the original frequency data. Goodness of fit statistics will be employed to determine whether assumptions underlying test statistics (e.g., normality) are satisfied. If assumptions for the test procedures are violated, then rank-transformed or arcsin-transformed data will be used. Probability tests will be two-sided.
Time frame: Up to 11 years
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)