Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
NCT ID: NCT00004064
Last Updated: 2013-11-06
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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UNKNOWN
PHASE2
102 participants
INTERVENTIONAL
1998-11-30
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients with disease progression after week 49 may receive MOAB B43.13 alone, in combination with, or following chemotherapy. Quality of life is assessed during the study.
PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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oregovomab
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active autoimmune disease requiring chronic treatment No allergy to murine proteins No documented anaphylactic reaction to any drug No active infection causing fever No immunodeficiency disease No uncontrolled nonmalignant diseases No other malignancy (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless curatively treated and free of disease for at least 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent immunosuppressive drugs At least 30 days since other prior investigational drugs
18 Years
FEMALE
No
Sponsors
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AltaRex
INDUSTRY
Principal Investigators
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Michael A. Bookman, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Gynecologic Oncology Associates
Newport Beach, California, United States
Lee Memorial Health System
Fort Myers, Florida, United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Palmetto Richland Memorial Hospital
Columbia, South Carolina, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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ALTAREX-OVA-Gy-10
Identifier Type: -
Identifier Source: secondary_id
OU-08111
Identifier Type: -
Identifier Source: secondary_id
CDR0000067265
Identifier Type: -
Identifier Source: org_study_id