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CompletedNCT00003688Updated Jun 10, 2013

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

A Phase 2 interventional study of dactinomycin in Gestational Trophoblastic Tumor, sponsored by Gynecologic Oncology Group. Completed at 29 sites in 2 countries. Open to female participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-06-10.

Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
12 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gestational Trophoblastic Tumor

Keywords

  • recurrent gestational trophoblastic tumor
  • nonmetastatic gestational trophoblastic tumor
  • low risk metastatic gestational trophoblastic tumor
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In context

Trophoblastic Neoplasms

46 studies on the registry are indexed under Trophoblastic Neoplasms; 7 are open to participants now.

Browse Trophoblastic Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
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Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Biologicaldactinomycin
06

Study locations

29 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
  • Community Hospital of Los Gatos
    Los Gatos, California 95032, United States
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
    Orange, California 92868, United States
  • MBCCOP - Hawaii
    Honolulu, Hawaii 96813, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Holden Comprehensive Cancer Center at University of Iowa
    Iowa City, Iowa 52242-1009, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • Tufts - New England Medical Center
    Boston, Massachusetts 02111, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Cooper University Hospital
    Camden, New Jersey 08103-1489, United States
  • State University of New York Health Science Center at Brooklyn
    Brooklyn, New York 11203, United States
  • Long Island Cancer Center at Stony Brook University Hospital
    Stony Brook, New York 11794-8091, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Comprehensive Cancer Center at Wake Forest University
    Winston-Salem, North Carolina 27157-1065, United States
  • Charles M. Barrett Cancer Center at University Hospital
    Cincinnati, Ohio 45267-0526, United States
  • Ireland Cancer Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio 43210-1240, United States
  • University of Oklahoma College of Medicine
    Oklahoma City, Oklahoma 73190, United States
  • Abington Memorial Hospital
    Abington, Pennsylvania 19001-3788, United States
  • Abramson Cancer Center at University of Pennsylvania Medical Center
    Philadelphia, Pennsylvania 19104-4283, United States
  • Brookview Research, Inc.
    Nashville, Tennessee 37203, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0587, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-3236, United States
  • CCOP - Marshfield Clinic Research Foundation
    Marshfield, Wisconsin 54449, United States
  • Norwegian Radium Hospital
    Oslo, N-0310, Norway
07

References and documents

Publications

  • Covens A, Filiaci VL, Burger RA, Osborne R, Chen MD; Gynecologic Oncology Group. Phase II trial of pulse dactinomycin as salvage therapy for failed low-risk gestational trophoblastic neoplasia: a Gynecologic Oncology Group study. Cancer. 2006 Sep 15;107(6):1280-6. doi: 10.1002/cncr.22118. PubMed 16900525 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003688
Lead sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Oct 1999
Primary completion
Sep 2006
Last update
Jun 10, 2013

Study contacts

Allan Covens, MD
study chair · Toronto Sunnybrook Regional Cancer Centre
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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