Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

NCT00003688 | Completed Phase 2

• 2 other identifiers: CDR0000066791GOG-176
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 29

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.

Conditions

Gestational Trophoblastic Tumor

Keywords

recurrent gestational trophoblastic tumor; nonmetastatic gestational trophoblastic tumor; low risk metastatic gestational trophoblastic tumor

Interventions

dactinomycin BIOLOGICAL

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (29)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794-8091, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0526, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-3236, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related 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):1280-6. doi: 10.1002/cncr.22118.

  PMID: 16900525 RESULT

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

Dactinomycin

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Allan Covens, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1999
• Primary Completion: September 1, 2006
• Last Updated: June 10, 2013

Record last verified: 2003-12

Locations

US (28); NO (1)