Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia|
|Study Start Date:||October 1999|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.