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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Paul Sabbatini

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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