Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- University of Virginia
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Safety of the Vaccine
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.
Detailed Description
OBJECTIVES: * Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer. OUTLINE: This is an open-label study. Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43. After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.
Investigators
Amir Jazaeri
Principal Investigator
University of Virginia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety of the Vaccine
Time Frame: Days 1,8,15,22,29,36,43,50
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Time Frame: Day 22
Secondary Outcomes
- Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay(Days 1,8,15,22,29,36,43,50 and Month 3)