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Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma Clinical research trials and Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma  Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
For Condition: Ovarian Neoplasms
Status: No longer recruiting
Sponsor(s): United Therapeutics ,
Synopsis: In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration. Group 1 will receive two doses, one month apart. Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses. Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses. The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and disease is classified as FIGO Stage III or IV. - Functional Performance Status < or = 2 by ECOG scale or > or = 60% on Karnofsky scale. - Medical assessment consistent with prognosis for an expected survival of at least 6 months. - Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL and immunohistochemical evidence of tumor tissue expressing CA125. - Presence of residual disease that is either (a) visible to or palpable by the surgeon at the completion of the staging laparotomy procedure, or (b) microscopic disease remaining following the staging laparotomy procedure. - Received chemotherapy that included cisplatin or carboplatin following appropriate staging procedure. - Complete clinical response to primary treatment protocol, which included laparotomy followed by platinum-based adjuvant chemotherapy. Exclusion Criteria: - First dose of study medication must be within 10 weeks of completing last dose of primary chemotherapy. - Not more than one prior regimen of chemotherapy. A change of chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen. - No whole abdomen, abdominopelvic or pelvic radiotherapy, surgery or chemotherapy within 4 weeks prior to first dose of study drug. - No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 6 weeks of first study dose. Patients who have received hemopoietic factors are acceptable. - No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes. - No compromised hematopoietic function defined as a hemoglobin <8.0 g/dL or lymphocyte count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3. - No hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits. - No severe renal dysfunction defined as serum creatinine >1.6 mg/dL. - While pregnancy is unlikely in view of the disease and previous surgery, patients who the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method. Patients who are breast-feeding are also excluded. - No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn?s Disease, MS, ankylosing spondylitis). - No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug. - Not on chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids. - No active infection causing fever. - No previous splenectomy. - No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies. - No uncontrolled diseases or illness other than this cancer. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible. - No significant cardiovascular abnormalities (uncontrolled hypertension, CHF (NYHA Classes II-IV), uncontrolled angina, or uncontrolled arrhythmias). - No concurrent illness or chronically taking medication that could confound the results of the study, preclude the patient from completing the study or mask an adverse reaction. - No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for > or = 5 years. - No other investigational drugs within 30 days of enrollment. - No contraindications present to the use of pressor agents. - Inability to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment. - Only tumors of low malignant potential or with noninvasive disease. - Not more than one interval debulking procedure.
Total Enrollment: 102
Location and Contact Information:
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States
Texas Oncology, P.A.
Dallas, Texas, 75246
United States
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Canada
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Stanford University Medical Center
Stanford, California, 94305
United States
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Swedish Medical Center Tumor Institute
Seattle, Washington, 98104
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32804
United States
Parker Hill Oncology & Hematology
Boston, Massachusetts, 02120
United States
St. Joseph's Regional Medical Center
South Bend, Indiana, 46617
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Cancer Care Manitoba
Winnipeg, Manitoba, R3E O9V
Canada
Gynecologic Oncology Associates
Newport Beach, California, 92663
United States
Additional Information:
Study ID Numbers: OVA-Gy-15;
Study Start Date: September 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034372
Other Ovarian Neoplasms Studies:
1. Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
2. Study of T900607-sodium in previously treated patients with ovarian cancer.
3. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
4. Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
5. Phase 1-2a Study of TLK286 in Combination with Doxil in Platinum Refractory or Resistant Ovarian Cancer
Related Studies:
Other Ovarian Neoplasms Clinical Trials
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Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
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