Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003688

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Trophoblastic Tumor	Biological: dactinomycin	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

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