Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
354 participants
INTERVENTIONAL
2002-12-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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oregovomab
Eligibility Criteria
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Inclusion Criteria
* Patients must have had an elevated serum CA125 level (per reference lab normal range) measured prior to or at surgery (i.e., not later than the immediate post-surgery period when the patient is in the surgical recovery room). If a pre-surgical CA125 measurement is not available, then the patient must have had: (a) a serum CA125 level ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical methods to express CA125.
* Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third cycle of front-line chemotherapy.
* Patients must have had microscopic or small diameter residual disease following primary de-bulking surgical procedure.
* Patients must have received chemotherapy that included a platinum compound and a taxane following appropriate staging procedures. Front-line treatment can include no more than 8 cycles of chemotherapy.
* Patients must have had a complete clinical response to their front-line surgery and chemotherapy. A complete clinical response is defined as one in which the patient had a normal physical examination, no conclusive evidence of residual tumor by CT of the abdomen and pelvis, a normal chest x-ray, and a serum CA125 level at least 5 U/mL but less than 35 U/mL as measured in the pretreatment baseline laboratories by the protocol Central Lab.
* Patients must have undergone no more than one interval de-bulking procedure.
* Patients must receive their first dose of study medication between 4 and 12 weeks after completing their last dose of front-line chemotherapy.
* Patients must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.
Exclusion Criteria
* Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian, tubal, or peritoneal origin requiring chemotherapy.
* Patients who have compromised hematopoietic function (hemoglobin \<8.0 g/dL; lymphocyte count \<300 mm³; neutrophil count \<1000 mm³; platelet count \<100,000 mm³.
* Patients with hepatic dysfunction defined as a bilirubin \>1.5 times the upper normal limits, LDH, SGOT and SGPT\>2 times upper limits of normal or albumin \<3.5 g/dL.
* Patients with severe renal dysfunction defined as a serum creatinine \>1.6 mg/dL.
* Patients with a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
* Patients who have contraindications to the use of pressor agents.
* Patients being chronically treated with immunosuppressive drugs such as cyclosporin, ACTH, or systemic corticosteroids.
* Patients who have received immunotherapy (interferons, tumor necrosis factor, other cytokines \[e.g., interleukins\] or biological response modifiers, or BCG vaccines) within 6 weeks of receiving their first dose of study medication. Patients who have received hemopoietic factors are acceptable.
* Patients who have had a splenectomy.
* Patients with uncontrolled diseases other than cancer will be excluded. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
* Patients who have a concurrent illness or chronically taking medication, which would confound the results of the study, preclude the patient from completing the study, or mask an adverse reaction.
* Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ carcinoma of cervix), unless the patient received curative treatment and has been disease free for greater than or equal to 5 years.
* Patients receiving other investigational drugs within 30 days of enrollment.
18 Years
FEMALE
No
Sponsors
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Unither Pharmaceuticals
INDUSTRY
Locations
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Comprehensive Cancer Institute
Huntsville, Alabama, United States
Western Regional Community Clinical Oncology Program
Phoenix, Arizona, United States
Little Rock Hematology Oncology Assoc.
Little Rock, Arkansas, United States
St. Jude Medical Center
Fullerton, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Gynecologic Oncology Associates
Newport Beach, California, United States
University of California, Irvine
Orange, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Stanford University
Stanford, California, United States
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, United States
University of Connecticut Cancer Center
Farmington, Connecticut, United States
Northwestern Connecticut Oncology Hematology Associates, LLP
Torrington, Connecticut, United States
Florida Gynecologic Oncology
Fort Myers, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
H. Lee Moffitt Cancer Center and Research
Tampa, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
The University of Chicago Hospitals
Chicago, Illinois, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States
Michiana Hematology Oncology PC
South Bend, Indiana, United States
Brown Cancer Center
Louisville, Kentucky, United States
Louisville Oncology
Louisville, Kentucky, United States
Lake Charles Medical Surgical Clinic
Lake Charles, Louisiana, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, United States
The Harry and Jeanette Weinberg Cancer Institute
Baltimore, Maryland, United States
New England Medical Center
Boston, Massachusetts, United States
Women's Specialty Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Nyack Hospital
Nyack, New York, United States
SUNY-HSC Syracuse, Crouse Hospital
Syracuse, New York, United States
Blumenthal Cancer Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospital - Health Systems
Cleveland, Ohio, United States
GYN Oncology and Pelvic Surgery Associates
Columbus, Ohio, United States
ProMedica Health Systems
Toledo, Ohio, United States
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists-Northrup
Portland, Oregon, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Brown University School of Medicine
Providence, Rhode Island, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Gynecologic Oncology Research and Development
Greenville, South Carolina, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States
West Clinic, PC
Memphis, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Univ. of Texas SW Medical Center at Dallas
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
VA Oncology Associates
Norfolk, Virginia, United States
Carilion GYN Oncology Associates
Roanoke, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States
Countries
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Other Identifiers
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OVA-Gy-17
Identifier Type: -
Identifier Source: org_study_id
NCT00068354
Identifier Type: -
Identifier Source: nct_alias