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
|ClinicalTrials.gov Identifier: NCT00857545|
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : September 6, 2017
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||July 2010|
|Primary Completion Date :||September 2015|
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
- Progression-free Survival (PFS) [ Time Frame: Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission. ]Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
- Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period [ Time Frame: During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks. ]Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years of follow-up. ]Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857545
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|Principal Investigator:||Paul Sabbatini||NRG Oncology|