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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004115 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is more effective than observation for ovarian cancer or primary peritoneal cancer that is in remission.
PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy.
| Condition | Intervention | Phase |
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: yttrium Y 90 monoclonal antibody HMFG1 |
Phase III |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium |
| Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, parallel, multicenter study. Patients are randomized to one of two treatment arms.
Quality of life is assessed in all patients prior to randomization, at weeks 4 and 8, at 3 months, and then every 3 months thereafter.
Patients in arm I are followed at weeks 1, 4, and 8. Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12. All patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 420 patients (210 per treatment arm) 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:
Prior complete response to 1 platinum-based chemotherapy regimen consisting of at least 5 courses
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United Kingdom, England | |||||
| Antisoma | |||||
| London, England, United Kingdom, W5 3QR | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Jonathan S. Berek, MD | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067341, UCLA-9712040, ANTISOMA-SMART22, NCI-G99-1604 |
| First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004115 |
| Health Authority: | United States: Federal Government |
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