OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission
NCT00857545 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171
Last updated 2017-09-13
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.
Conditions
- Stage 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
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Polyvalent Antigen-KLH Conjugate Vaccine
Given SC
- BIOLOGICAL
-
Saponin-based Immunoadjuvant OBI-821
Given SC
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Gynecologic Oncology Group
lead NETWORK
Principal Investigators
-
Paul Sabbatini · NRG Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2015-09-30
Countries
- United States
Study Locations
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