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Spots Global Cancer Trial Database for Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

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Trial Identification

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

Interventions

dactinomycin

Study Description

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.

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Allan Covens, MD

Affiliation: Toronto Sunnybrook Regional Cancer Centre

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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