Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: oregovomab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease |
| Estimated Enrollment: | 102 |
| Study Start Date: | November 1998 |
OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum, but without other evidence of disease. II. Determine the time to disease progression, overall survival, CA 125 levels, immune responses, and quality of life of these patients treated with this regimen.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or clinical evidence of disease No disease recurrence Must have received only 1 prior platinum based chemotherapy regimen No tumors of low malignant potential or noninvasive disease
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
Contacts and Locations| United States, California | |
| Gynecologic Oncology Associates | |
| Newport Beach, California, United States, 92663 | |
| United States, Florida | |
| Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33902 | |
| Walt Disney Memorial Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Mercy Medical Center, Inc. | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| St. John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Oklahoma | |
| University of Oklahoma College of Medicine | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, South Carolina | |
| Palmetto Richland Memorial Hospital | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Texas Oncology, P.A. | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Riverside Regional Medical Center | |
| Newport News, Virginia, United States, 23601 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Center - General Division | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Study Chair: | Michael A. Bookman, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004064 History of Changes |
| Other Study ID Numbers: | CDR0000067265, ALTAREX-OVA-Gy-10, OU-08111 |
| Study First Received: | December 10, 1999 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on June 17, 2013