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
• Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): GOG Foundation ( Gynecologic Oncology Group )

Tracking Information

• First Submitted Date: March 5, 2009
• First Posted Date: March 6, 2009
• Results First Submitted Date: December 20, 2016
• Results First Posted Date: September 6, 2017
• Last Update Posted Date: September 13, 2017
• Study Start Date: July 2010
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2017)

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.

• Original Primary Outcome Measures (submitted: March 5, 2009): Progression-free survival

Current Secondary Outcome Measures (submitted: August 7, 2017)

• 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.

Original Secondary Outcome Measures (submitted: March 5, 2009)

• Overall survival
• Frequency and severity of adverse effects as assessed by NCI CTCAE v3.0 criteria
• Correlation of outcome with antigen-specific immune titers

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• 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

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Other: Laboratory Biomarker Analysis
  • Biological: Polyvalent Antigen-KLH Conjugate Vaccine
  • Biological: Saponin-based Immunoadjuvant OBI-821
• Experimental: Arm II (adjuvant)
  Patients receive immunological adjuvant OPT-821 SC as in arm I.
  Interventions:

  • Other: Laboratory Biomarker Analysis
  • Biological: Saponin-based Immunoadjuvant OBI-821

• Publications *: O'Cearbhaill RE, Deng W, Chen LM, Lucci JA 3rd, Behbakht K, Spirtos NM, Muller CY, Benigno BB, Powell MA, Berry E, Tewari KS, Hanjani P, Lankes HA, Aghajanian C, Sabbatini PJ. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study. Gynecol Oncol. 2019 Dec;155(3):393-399. doi: 10.1016/j.ygyno.2019.09.015. Epub 2019 Oct 22.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 7, 2017): 171
• Original Estimated Enrollment (submitted: March 5, 2009): 164
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00857545
• Other Study ID Numbers: GOG-0255; NCI-2009-01176 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000636384; GOG-0255 ( Other Identifier: NRG Oncology ); GOG-0255 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract ); U10CA027469 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
• Original Responsible Party: Not Provided
• Current Study Sponsor: Gynecologic Oncology Group
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Paul Sabbatini; NRG Oncology

• PRS Account: GOG Foundation
• Verification Date: December 2016