Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
NCT ID: NCT00003688
Last Updated: 2013-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia.
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Detailed Description
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* 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
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Study Design
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TREATMENT
Interventions
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dactinomycin
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
50 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Allan Covens, MD
Role: STUDY_CHAIR
Toronto Sunnybrook Regional Cancer Centre
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cooper University Hospital
Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Norwegian Radium Hospital
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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GOG-176
Identifier Type: -
Identifier Source: secondary_id
CDR0000066791
Identifier Type: -
Identifier Source: org_study_id
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