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 recurrentgestational trophoblastic neoplasia.

Condition	Treatment or Intervention	Phase
recurrent gestational trophoblastic tumor nonmetastatic gestational trophoblastic tumor good prognosis metastatic gestational trophoblastic tumor	Drug: dactinomycin  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  12 Years   -   50 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Allan Covens, MD,  Study Chair,  Toronto Sunnybrook Regional Cancer Centre   

Study ID Numbers:  CDR0000066791; GOG-176
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003688
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08