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Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003688
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Tumor Biological: dactinomycin Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Study Start Date : October 1999
Actual Primary Completion Date : September 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed complete or partial mole on initial evaluation

    • Current diagnosis of persistent or recurrent low-risk gestational trophoblastic neoplasia, defined by 1 of the following criteria:

      • Less than 10% fall in beta-human chorionic gonadotropin (HCG) over 3 consecutive weekly titers
      • More than 20% rise in beta-HCG over the previous value at any time
      • Rise in beta-HCG (greater than 5 mU/mL) after attaining normal level
  • Prior treatment limited to methotrexate (MTX) with or without leucovorin calcium (CF)
  • WHO score 2-6 at time of relapse
  • Must have undergone at least 1 prior curettage for diagnosis and initial management
  • No metastatic disease other than lung or vagina on physical examination, chemistry, chest x-ray, or ultrasound
  • No more than 8 metastatic lesions
  • No histologically confirmed placental site trophoblastic tumor at initial evaluation



  • 12 to 50

Performance status

  • GOG 0-1

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal


  • Creatinine no greater than 1.5 mg/dL


  • No significant infection
  • No more than 1 year since prior pregnancy
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • At least 1 week since prior chemotherapy and recovered
  • No prior chemotherapeutic drugs other than MTX with or without CF

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics
  • Recovered from prior surgery
  • No concurrent curettage unless required to control vaginal bleeding


  • No prior anticancer treatment that would preclude study therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003688

  Show 29 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: Allan Covens, MD Toronto Sunnybrook Regional Cancer Centre

Publications of Results:
Layout table for additonal information Identifier: NCT00003688     History of Changes
Other Study ID Numbers: CDR0000066791
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: December 2003
Keywords provided by Gynecologic Oncology Group:
recurrent gestational trophoblastic tumor
nonmetastatic gestational trophoblastic tumor
low risk metastatic gestational trophoblastic tumor
Additional relevant MeSH terms:
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Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors