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Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer. Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer  Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
For Condition: stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Surgically debulked stage III or IV ovarian epithelial cancer; Must be able to obtain adequate number of viable cells from excised tumor mass; Must have received 6 courses of combination chemotherapy comprised of either paclitaxel and cisplatin OR paclitaxel and carboplatin - Must be clinically tumor free following completion of chemotherapy (i.e., no metastasis by physical examination and CT of the abdomen and pelvis and serum CA-125 less than 35 IU/L) - Not on a Phase III GOG protocol --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidBerd, Study Chair, Gynecologic Oncology Group
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000066382; GOG-9802
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003386
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
2. Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
3. High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
4. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
5. Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
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