CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 171 enrolled
Drug / intervention
Polyvalent Antigen-KLH Conjugate Vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00857545
NCT00857545Phase 2Completed
CompareCT.gov

A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 ) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission

Gynecologic Oncology Group·interventional·Posted Mar 6, 2009·Updated Sep 13, 2017

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Polyvalent Antigen-KLH Conjugate Vaccine, and 1 other intervention for Stage IA Fallopian Tube Cancer and 23 related conditions. Completed, enrolled 171 participants across 46 sites.

Detailed Summary

This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer, Stage IB Ovarian Cancer, Stage IC Fallopian Tube Cancer, Stage IC Ovarian Cancer, Stage IIA Fallopian Tube Cancer, Stage IIA Ovarian Cancer, Stage IIB Fallopian Tube Cancer, Stage IIB Ovarian Cancer, Stage IIC Fallopian Tube Cancer, Stage IIC Ovarian Cancer, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2009
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.3 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Polyvalent Antigen-KLH Conjugate Vaccinebiological

Given SC

Saponin-based Immunoadjuvant OBI-821biological

Given SC