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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT00857545
Run by: Gynecologic Oncology Group
People needed: 171
Starts: 2010-07-01
Last updated by the study team: 2017-09-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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 — St 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

Full record on ClinicalTrials.gov

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