Gestational Trophoblastic Tumor
Conditions
Keywords
recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor, low risk metastatic gestational trophoblastic tumor
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.
Detailed description
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.
Interventions
BIOLOGICALdactinomycin
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Countries
Norway, United States
Outcome results
None listed