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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
Study ID: NCT00857545
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Saint Vincent Oncology Center, Indianapolis, Indiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Gynecologic Oncology of West Michigan PLLC, Grand Rapids, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, 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
University of New Mexico Cancer Center, 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
Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
University of Cincinnati, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Toledo, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Paul Sabbatini
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR