Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Gestational Trophoblastic Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003688
• Other study ID #: CDR0000066791
• Secondary ID: GOG-176
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 7, 2013
• Start date: October 1999

Study information

• Verified date: December 2003
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Trophoblastic Neoplasms

Intervention

Biological:
• dactinomycin

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
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	University of Mississippi Medical Center	Jackson	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (1)

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 — View Citation