Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

Phase 1

Completed

• Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00091273
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-08
• Study First Posted: 2004-09-09
• Primary Completion: 2006-02
• Study Completion: 2007-06
• Status Verified: 2014-05
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Results First Posted: 2014-06-20
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of the Vaccine	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	Day 22

Secondary Outcome Measures

Name	Time	Method
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay	Days 1,8,15,22,29,36,43,50 and Month 3

Trial Locations

Locations (1)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States