A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
oregovomab
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: April 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Compare the time to disease relapse, survival, and quality of life of patients with stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma treated with OvaRex monoclonal antibody B43.13 OR placebo following complete clinical response to primary therapy. II. Determine the safety of this regimen in these patients. III. Assess the immune response of patients treated with this regimen. OUTLINE: This is a randomized study. Patients undergo a laparotomy and platinum based chemotherapy prior to randomization. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive OvaRex monoclonal antibody B43.13 IV on day 0. Treatment continues at 4, 8, 20, 32, 44, and 56 weeks, and then every 3 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo IV on day 0. Placebo administration continues on the same schedule as in arm I. Patients presenting with relapse are provided with second line chemotherapy. Quality of life is assessed at the beginning of the study, after 2 months, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma Must have had complete clinical response to primary therapy consisting of surgical debulking and platinum based chemotherapy Elevated CA 125 (greater than 35 U/mL) prior to or at surgery (if presurgical CA 125 measurement is not available, patient must have a serum CA 125 of at least 100 U/mL and strong tumor tissue expression) Must have residual disease (visible or palpable) at completion of the staging laparotomy (IIIB and IIIC microscopic disease) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 300/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No prior murine monoclonal antibodies for diagnostic or therapeutic purposes Chemotherapy: No more than 1 prior regimen of chemotherapy (change in chemotherapy agents is permitted during primary therapy provided that the change is considered to be part of initial chemotherapy regimen) At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior abdominal, abdominopelvic, or pelvic radiotherapy Surgery: At least 4 weeks since prior surgery No more than 1 interval debulking procedure
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 46 locations
Alta Bates Comprehensive Cancer Center
Berkeley, United StatesOpen Alta Bates Comprehensive Cancer Center in Google MapsUSC/Norris Comprehensive Cancer Center
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesChao Family Comprehensive Cancer Center
Orange, United States