Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
NCT ID: NCT00003386
Last Updated: 2013-04-11
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
PHASE2
INTERVENTIONAL
1999-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV ovarian epithelial cancer.
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Detailed Description
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OUTLINE: Patients undergo a standard debulking procedure with the tumor tissue being sent to Thomas Jefferson University. Patients then receive six courses of combination chemotherapy consisting of either paclitaxel and cisplatin or paclitaxel and carboplatin. Vaccine therapy must commence within 4-12 weeks of completion of chemotherapy. Patients are tested for delayed-type hypersensitivity (DTH) on day -7. Cyclophosphamide IV is administered on day 0. Dinitrophenyl (DNP)-modified autologous ovarian epithelial cell vaccine and BCG adjuvant are injected once a week beginning on day 3 and continuing for 6 weeks. DTH testing is repeated at week 8. Booster vaccine injections are administered at 6 and 12 months if patient is disease free. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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BCG vaccine
autologous tumor cell vaccine
carboplatin
cisplatin
cyclophosphamide
paclitaxel
dinitrophenyl
surgical procedure
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0 or 1 Hematopoietic: Hematocrit at least 25% WBC at least 3,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No active infections HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No active autoimmune disease No prior invasive malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics 4-12 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior major field radiotherapy Surgery: See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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David Berd, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Radiation Oncology Branch
Bethesda, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
CCOP - Sooner State
Tulsa, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Countries
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Other Identifiers
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GOG-9802
Identifier Type: -
Identifier Source: secondary_id
CDR0000066382
Identifier Type: -
Identifier Source: org_study_id
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