NCT00003688

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Trophoblastic Tumor

Interventions

Type	Name	Description
BIOLOGICAL	dactinomycin

Timeline

• Start date: 1999-10-01
• Primary completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2013-06-10

Locations

29 sites across 2 countries: United States, Norway