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

Primary Purpose

Recurrent Melanoma, Stage IA Skin Melanoma, Stage IB Skin Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gp100:209-217(210M) Peptide Vaccine
HPV 16 E7:12-20 Peptide Vaccine
Laboratory Biomarker Analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Providence Portland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vaccine therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2013
Last Updated
January 23, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01989559
Brief Title
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
Official Title
A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vaccine therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
gp100:209-217(210M) Peptide Vaccine
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
HPV 16 E7:12-20 Peptide Vaccine
Other Intervention Name(s)
HPV-16 E7(12-20) peptide, HPV-16E7(12-20) peptide vaccine, HPV16 E7(12-20) peptide, HPV16 E7(12-20) peptide vaccine
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Percentage of positive CD8+ T cells
Description
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
Title
Change in CD8+ T cell frequency
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Urba
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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