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Brief Title: Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Official Title: Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Study ID: NCT00003688
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: No
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
University of Mississippi Medical Center, Jackson, Mississippi, United States
Cooper University Hospital, Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York, United States
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Brookview Research, Inc., Nashville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Norwegian Radium Hospital, Oslo, , Norway
Name: Allan Covens, MD
Affiliation: Toronto Sunnybrook Regional Cancer Centre
Role: STUDY_CHAIR