Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
- Conditions
- Gestational Trophoblastic Tumor
- Registration Number
- NCT00003688
- Lead Sponsor
- Gynecologic Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States