dactinomycin in treating patients with persistent or recurrent gestational trophoblastic neoplasia

Conditions: Gestational Trophoblastic Tumor

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.

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.

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

Keywords: recurrent gestational trophoblastic tumor nonmetastatic gestational trophoblastic tumor low risk metastatic gestational trophoblastic tumor