Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00003386
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV ovarian epithelial cancer.
- Detailed Description
OBJECTIVES: I. Determine whether patients with surgically debulked ovarian epithelial cancer develop delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine. II. Assess the toxic effects of this regimen in these patients. III. Determine the feasibility of conducting a group wide vaccine study.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, 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
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
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Sooner State
🇺🇸Tulsa, Oklahoma, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States