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

Phase 2

Completed

Conditions: Stage IC Ovarian Cancer
Stage IB Fallopian Tube Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IA Fallopian Tube Cancer
Stage IC Fallopian Tube Cancer
Stage IIB Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IA Ovarian Cancer

Interventions: Other: Laboratory Biomarker Analysis
Biological: Polyvalent Antigen-KLH Conjugate Vaccine
Biological: Saponin-based Immunoadjuvant OBI-821

Registration Number: NCT00857545

Lead Sponsor: Gynecologic Oncology Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 171

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (vaccine therapy and adjuvant)	Laboratory Biomarker Analysis	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 I (vaccine therapy and adjuvant)	Polyvalent Antigen-KLH Conjugate Vaccine	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 (adjuvant)	Laboratory Biomarker Analysis	Patients receive immunological adjuvant OPT-821 SC as in arm I.
Arm II (adjuvant)	Saponin-based Immunoadjuvant OBI-821	Patients receive immunological adjuvant OPT-821 SC as in arm I.
Arm I (vaccine therapy and adjuvant)	Saponin-based Immunoadjuvant OBI-821	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period	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	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.

Trial Locations

Locations (45): Gynecologic Oncology of West Michigan PLLC
🇺🇸
Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸
Miami, Florida, United States
Northside Hospital
🇺🇸
Atlanta, Georgia, United States
Greater Baltimore Medical Center
🇺🇸
Baltimore, Maryland, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
🇺🇸
Warrenville, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸
Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
UCSF Medical Center-Mount Zion
🇺🇸
San Francisco, California, United States
Huntsman Cancer Institute/University of Utah
🇺🇸
Salt Lake City, Utah, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸
Mobile, Alabama, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
Beebe Medical Center
🇺🇸
Lewes, Delaware, United States
Stanford Cancer Institute
🇺🇸
Palo Alto, California, United States
Christiana Care Health System-Christiana Hospital
🇺🇸
Newark, Delaware, United States
Saint Vincent Oncology Center
🇺🇸
Indianapolis, Indiana, United States
Women's Cancer Center of Nevada
🇺🇸
Las Vegas, Nevada, United States
Center of Hope at Renown Medical Center
🇺🇸
Reno, Nevada, United States
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
🇺🇸
Phillipsburg, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
Southwest Gynecologic Oncology Associates Inc
🇺🇸
Albuquerque, New Mexico, United States
Winthrop University Hospital
🇺🇸
Mineola, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸
Charlotte, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center
🇺🇸
Akron, Ohio, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
🇺🇸
Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Miami Valley Hospital
🇺🇸
Dayton, Ohio, United States
University of Toledo
🇺🇸
Toledo, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
Kettering Medical Center
🇺🇸
Kettering, Ohio, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
AnMed Health Cancer Center
🇺🇸
Anderson, South Carolina, United States
Greenville Health System Cancer Institute-Faris
🇺🇸
Greenville, South Carolina, United States
Saint Francis Hospital
🇺🇸
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸
Greenville, South Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸
Richmond, Virginia, United States
Froedtert and the Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Carilion Clinic Gynecological Oncology
🇺🇸
Roanoke, Virginia, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸
Spartanburg, South Carolina, United States
Union Hospital of Cecil County
🇺🇸
Elkton, Maryland, United States