Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Trophoblastic Tumor

Intervention / Treatment
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* Biological: dactinomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: dactinomycin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor, low risk metastatic gestational trophoblastic tumor