Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
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.
Primary Peritoneal Cavity Cancer
Biological: incomplete Freund's adjuvant
Biological: ovarian cancer peptide vaccine
Biological: tetanus toxoid helper peptide
Procedure: adjuvant therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer|
- Safety of the Vaccine [ Time Frame: Days 1,8,15,22,29,36,43,50 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay [ Time Frame: Days 1,8,15,22,29,36,43,50 and Month 3 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||June 2007|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091273
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Amir A. Jazaeri, MD||University of Virginia|