A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope Folate Receptor Alpha Peptide Vaccine Used in Combination With Cyclophosphamide in Subjects Previously Treated for Breast or Ovarian Cancer
I. To assess the safety of administering a course of cyclophosphamide treatment followed by
six subsequent monthly vaccinations with a peptide-based vaccine targeting folate receptor 1
(FR)-alpha (multi-epitope folate receptor alpha peptide vaccine).
II. To assess the ability of this vaccination protocol to elicit an immune response as
measured by activated FR-alpha-specific T lymphocytes or high-affinity antibodies.
I. To determine FR-alpha expression status of primary tumors when available as
formalin-fixed, paraffin-embedded material and whether expression correlates with the
ability to generate an immune response.
II. To identify human lymphocyte antigen (HLA) class I binding peptides from FR-alpha that
are recognized by lymphocytes from patients prior to and after vaccination.
Patients receive 100 mg cyclophosphamide orally daily for 1 week followed by a 1 week rest,
and then another week of cyclophosphamide. Approximately 7-10 days after the last dose of
cyclophosphamide, patients receive multi-epitope folate receptor alpha peptide vaccine
intradermally (ID) on day 1. Vaccine treatment repeats every 28 days for up to 6 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who experience severe toxicities (grades 3-5 of the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events, version 4.0)at 12 months.
Defined as adverse events that are classified as either unrelated, unlikely to be related, possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by primary disease site to determine toxicity patterns.
Up to 12 months after completion of study treatment
United States: Food and Drug Administration
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