NCT00003688已完成2 期
Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 58
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •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
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •Alkaline phosphatase no greater than 3 times normal
- •Creatinine no greater than 1.5 mg/dL
- •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
- •See Disease Characteristics
- •Recovered from prior surgery
- •No concurrent curettage unless required to control vaginal bleeding
- •No prior anticancer treatment that would preclude study therapy
排除标准
- 未提供
研究者
研究点 (58)
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