Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery

NCT01989559 | Completed Phase 1

• 7 other identifiers: NCI-2013-02097PPMC-IRB-02-63NCI-5925CDR000025847902-635925R21CA099265
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Melanoma; Stage IA Skin Melanoma; Stage IB Skin Melanoma; Stage IIA Skin Melanoma; Stage IIB Skin Melanoma; Stage IIC Skin Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 11 years

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

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

Interventions

gp100:209-217(210M) Peptide Vaccine BIOLOGICAL

Given SC

Treatment (vaccine therapy)

HPV 16 E7:12-20 Peptide Vaccine BIOLOGICAL

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

Treatment (vaccine therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have completed treatment on protocol 99-9 \[T98-0081\] "A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide Vaccine in HLA-A2.1+ Patients with a \> 1mm Melanoma on Initial Biopsy;" patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose limiting toxicity
• Patients must be \>= 12 months from their last vaccination with gp100 and be free of melanoma; patients who have remained continuously free of disease and patients who have had a recurrence that has been completely resected (stage IV no evidence of disease \[NED\]) are eligible
• Patients must have a good performance status (Karnofsky performance status \[PS\] 80-100)
• White blood cells (WBC) \>= 3500/mm\^3
• Platelets (plt) \>= 100,000/mm\^3
• Hemoglobin \>= 9 gm/100 ml
• Serum creatinine =\< 2 mg/dl
• Total bilirubin =\< 2.0 mg/dl
• Patients must have recovered from any effects of major surgery and be free of significant systemic infection
• Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment; men must avoid fathering a child while on treatment
• Patients must give written informed consent prior to initiation of therapy
• Patients with a history of psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy

You may not qualify if:

• Patients must not have clinically detectable melanoma
• Patients who require or are likely to require systemic corticosteroids for intercurrent illness are ineligible
• Patients with any significant medical disease other than the melanoma, which in the opinion of the investigator would significantly increase the risk of immunotherapy, are ineligible
• Patients should be free of any other cancers or deemed at low risk for their recurrence

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Protein Subunit Vaccines; Peptides

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; Amino Acids, Peptides, and Proteins

Study Officials

• Walter Urba

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 21, 2013
• Study Start: October 1, 2002
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 26, 2015

Record last verified: 2013-11

Locations

US (1)