Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gestational Trophoblastic Tumor
Intervention: dactinomycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gynecologic Oncology Group Official(s) and/or principal investigator(s):
Allan Covens, MD, Study Chair, Affiliation: Edmond Odette Cancer Centre at Sunnybrook
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.
Clinical Details
Official title: Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Study design: Treatment
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
Minimum age: 12 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Norwegian Radium Hospital, Oslo N-0310, Norway
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California 92868, United States
Community Hospital of Los Gatos, Los Gatos, California 95032, 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
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York 11794-8091, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York 11203, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1065, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267-0526, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
Ireland Cancer Center, Cleveland, Ohio 44106, 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
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-3236, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1999
Last updated: May 23, 2008
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