search
Back to results

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Primary Purpose

Gestational Trophoblastic Tumor

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dactinomycin
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Tumor focused on measuring recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor, low risk metastatic gestational trophoblastic tumor

Eligibility Criteria

12 Years - 50 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Community Hospital of Los Gatos
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  • MBCCOP - Hawaii
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center at University of Iowa
  • Albert B. Chandler Medical Center, University of Kentucky
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Tufts - New England Medical Center
  • University of Minnesota Cancer Center
  • University of Mississippi Medical Center
  • Cooper University Hospital
  • State University of New York Health Science Center at Brooklyn
  • Long Island Cancer Center at Stony Brook University Hospital
  • Lineberger Comprehensive Cancer Center, UNC
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Charles M. Barrett Cancer Center at University Hospital
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • University of Oklahoma College of Medicine
  • Abington Memorial Hospital
  • Abramson Cancer Center at University of Pennsylvania Medical Center
  • Brookview Research, Inc.
  • University of Texas Medical Branch
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Norwegian Radium Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003688
Brief Title
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Official Title
Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Tumor
Keywords
recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor, low risk metastatic gestational trophoblastic tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
dactinomycin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Covens, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
State University of New York Health Science Center at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0526
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
Abramson Cancer Center at University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3236
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
16900525
Citation
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.
Results Reference
result

Learn more about this trial

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

We'll reach out to this number within 24 hrs