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Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia (NCT00003688)

National Cancer Institute (NCI)
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.
  • Biological: dactinomycin
    Ages eligible for Study
    12 Years to 50 Years
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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.

    29 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 September, 1999
    Updated:
    06 June, 2013
    Participants:
    0
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