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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00857545
First received: March 5, 2009
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
This randomized phase III 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.

Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 163
Study Start Date: July 2010
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 studies
Biological: Polyvalent Antigen-KLH Conjugate Vaccine
Given SC
Biological: Saponin-based Immunoadjuvant OBI-821
Given SC
Other Names:
  • OBI-821
  • OPT-821
Experimental: Arm II (adjuvant)
Patients receive immunological adjuvant OPT-821 SC as in arm I.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Saponin-based Immunoadjuvant OBI-821
Given SC
Other Names:
  • OBI-821
  • OPT-821

Detailed Description:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
  • Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
  • Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1
  • Platelets greater than or equal to 100,000/mm^3
  • Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
  • Bilirubin less than or equal to 2.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse (SGPT) less than or equal to 2.5 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
  • Patients who have signed the informed consent document and signed the authorization permitting release of personal health information
  • Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded

Exclusion Criteria:

  • With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
  • Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
  • Patients who have an allergy to shellfish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857545

  Show 46 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul Sabbatini NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00857545     History of Changes
Other Study ID Numbers: GOG-0255  NCI-2009-01176  CDR0000636384  GOG-0255  GOG-0255  U10CA180868  U10CA027469 
Study First Received: March 5, 2009
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Vaccines
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016