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Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003688
First received: November 1, 1999
Last updated: January 7, 2012
Last verified: December 2003
History of Changes
  Purpose

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 Intervention Phase
Gestational Trophoblastic Tumor
 Biological: dactinomycin
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
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.

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 12 to 50

Performance status

  • GOG 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine no greater than 1.5 mg/dL

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • Not specified

Surgery

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

Other

  • No prior anticancer treatment that would preclude study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003688

  Show 29 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Allan Covens, MD Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00003688     History of Changes
Other Study ID Numbers: CDR0000066791, GOG-176
Study First Received: November 1, 1999
Last Updated: January 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent gestational trophoblastic tumor
nonmetastatic gestational trophoblastic tumor
low risk metastatic gestational trophoblastic tumor

Additional relevant MeSH terms:
Neoplasms
Trophoblastic Neoplasms
Gestational Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Dactinomycin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013