Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Phase 2
12 Years
50 Years
12 Years
50 Years
Not Enrolling
Female
Gestational Trophoblastic Tumor
Female
Gestational Trophoblastic Tumor
Trial Information
Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Allan Covens, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Odette Cancer Centre at Sunnybrook
Authority:
United States: Federal Government
Study ID:
CDR0000066791
NCT ID:
NCT00003688
Start Date:
October 1999
Completion Date:
Related Keywords:
- Gestational Trophoblastic Tumor
- recurrent gestational trophoblastic tumor
- nonmetastatic gestational trophoblastic tumor
- low risk metastatic gestational trophoblastic tumor
- Neoplasms
- Trophoblastic Neoplasms
- Gestational Trophoblastic Neoplasms
Name | Location |
|---|---|
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Community Hospital of Los Gatos | Los Gatos, California 95032 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Brookview Research, Inc. | Nashville, Tennessee 37203 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| Tufts - New England Medical Center | Boston, Massachusetts 02111 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
