Ovarian Cancer Clinical Trial
Official title:
Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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