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
|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||Other: Laboratory Biomarker Analysis Biological: Polyvalent Antigen-KLH Conjugate Vaccine Biological: Saponin-based Immunoadjuvant OBI-821||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival (PFS) [ Time Frame: From randomization to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, assessed up to 5 years ]Characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death or progression. A stratified log-rank test will be used to examine whether the two treatment groups are different after stratifying by second or third complete remission (CR). Second, a Cox proportional hazards model will be used to test the interaction of treatment arm and 2nd/3rd CR.
- Immunoglobulin (Ig)M and IgG antibody titers by ELISA to antigens Tn-MUC1-32mer, GM2, Globo-H, TF, sialyl Tn (sTN), and Tn [ Time Frame: Up to 83 weeks ]Analyses will be conducted on the measures of immune response to assess the effects of the study regimens on these endpoints and to determine whether these endpoints are associated with clinical outcomes (PFS and overall survival). Immune response will be measured at repeated time points (week 1 [prior to treatment], and weeks 11, 17, 23, 35, 47, 59, 71, and 83). Therefore, the relationship of immune response with PFS and overall survival will be examined with Cox proportional hazards models with immune response as a time-dependent covariate.
- Incidence of adverse effects as assessed by National Cancer Institute (NCI) CTCAE v4.0 criteria [ Time Frame: Up to 87 weeks ]Frequency and severity of adverse events will be summarized with descriptive statistics for the patients in the safety analysis dataset.
- Overall survival [ Time Frame: From entry onto the protocol to death due to any cause, or for living patients, date of last contact, assessed up to 5 years ]Will be characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death. The log rank test will be used to compare treatment groups with respect to overall survival.
|Study Start Date:||July 2010|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I (vaccine therapy and adjuvant)
Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Polyvalent Antigen-KLH Conjugate Vaccine
Given SCBiological: Saponin-based Immunoadjuvant OBI-821
Experimental: Arm II (adjuvant)
Patients receive immunological adjuvant OPT-821 SC as in arm I.
Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Saponin-based Immunoadjuvant OBI-821
I. To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH], Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus OPT-821) decreases the hazard of progression or death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
I. To compare the treatment arms with respect to the incidence of toxicities. II. To determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
I. To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in participants, in order to determine if the outcome correlates with antigen-specific immune titers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive immunological adjuvant OPT-821 SC as in Arm I.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857545
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|Principal Investigator:||Paul Sabbatini||NRG Oncology|