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

Date de début de l'étude : 1 octobre 1999

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