RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia.
OBJECTIVES: * Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk gestational trophoblastic neoplasia. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive dactinomycin IV over 15 minutes on day 1. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients who achieve normal beta-human chorionic gonadotropin (HCG) receive 2 additional courses after attaining normal beta-HCG. Patients are followed every 2 weeks for 2 months and then monthly for 10 months. PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 18-42 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
...and 19 more locations