Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission
- Conditions
- Primary Peritoneal Cavity CancerOvarian CancerFallopian Tube Cancer
- Interventions
- Biological: immunological adjuvant OPT-821Biological: polyvalent antigen-KLH conjugate vaccine
- Registration Number
- NCT00693342
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Vaccines made from tumor antigens may help the body build an effective immune response to kill tumor cells. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with OPT-821 may kill more tumor cells. It is not yet known whether giving vaccine therapy together with OPT-821 is more effective than OPT-821 alone in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase III trial is studying vaccine therapy and OPT-821 to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer in complete remission.
- Detailed Description
OBJECTIVES:
Primary
* To compare the progression-free survival of patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer in second or third complete clinical remission treated with a polyvalent antigen-KLH conjugate vaccine (GM2-KLH, Globo-H-KLH, Tn-MUC1-32mer-KLH, TF-KLH, and sTn-KLH) in combination with OPT-821 vs OPT-821 alone.
Secondary
* To compare the incidence of toxicities in patients treated with these regimens.
* To compare the overall survival of patients treated with these regimens.
* To characterize the immune response (by ELISA) in a limited sampling of patients, in order to determine if the outcome correlates with antigen-specific immune titers.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive polyvalent antigen-KLH conjugate vaccine in combination with OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
* Arm II: Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for antibody expression to antigens (i.e., Tn-MUC1-32mer, GM2, Globo-H, TF, sTN, and Tn) by ELISA. IgM and IgG titers are also measured.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I immunological adjuvant OPT-821 Patients receive polyvalent antigen-KLH conjugate vaccine in combination with OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87. Arm I polyvalent antigen-KLH conjugate vaccine Patients receive polyvalent antigen-KLH conjugate vaccine in combination with OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87. Arm II immunological adjuvant OPT-821 Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Correlation of outcome with antigen-specific immune titers in a limited sampling of patients Incidence of toxicities Overall survival