CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
incomplete Freund's adjuvant +4 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed epithelial ovarian or primary peritoneal cancer
  • ✓Completed primary therapy (surgery and chemotherapy) within past 12 months
  • ✓Clinical or radiographic evidence of disease, OR serologic evidence of disease, OR stage III/IV at diagnosis with completed anticancer therapy within 12 months
  • ✓HLA-A1-, -A2-, or -A3-positive
Key exclusion· 10
  • ✕New York Heart Association class III or IV heart disease
  • ✕HIV positive
  • ✕Hepatitis C positive
  • ✕Active infection requiring antibiotics

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091273
NCT00091273Phase 1Completed
CompareCT.gov

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

University of Virginia·interventional·Posted Sep 9, 2004·Updated Jun 20, 2014

In Brief

A Phase 1 clinical trial evaluating incomplete Freund's adjuvant, ovarian cancer peptide vaccine, and 3 other interventions for Ovarian Cancer and Primary Peritoneal Cavity Cancer. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Primary Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2004
Enrollment StartJun 1, 2004
Primary CompletionFeb 1, 2006
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 21.8 years ago

Interventions

incomplete Freund's adjuvantbiological

ovarian cancer peptide vaccinebiological

sargramostimbiological

tetanus toxoid helper peptidebiological

adjuvant therapyprocedure