Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 41
- 试验地点
- 96
- 主要终点
- Disease-free survival at 3 years after study registration
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.
详细描述
OBJECTIVES:
- Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of embryonal rhabdomyosarcoma
- •Primary operation for pathological diagnosis within the past 42 days
- •The following variants are eligible:
- •Spindle cell
- •Anaplastic
- •Meets 1 of the following stage criteria:
- •Stage I, clinical group II (N1)
- •Favorable site
- •Any tumor size
- •Microscopic residual disease
- •Lymph nodes clinically positive
- •Stage I, clinical group III (N1)
- •Favorable site (orbit only)
- •Any tumor size
- •Gross residual disease
- •Lymph nodes clinically positive
- •Stage I, clinical group III (N0, NX, N1)
- •Favorable site (except orbit)
- •Any tumor size
- •Gross residual disease
- •Lymph nodes clinically negative, involvement unknown, or positive
- •Stage II, clinical group II (N0, NX)
- •Unfavorable site
- •Small tumor (≤ 5 cm in diameter)
- •Microscopic residual disease
- •Stage III, clinical group I or II (N0, NX, N1)
- •Unfavorable site
- •Small tumor (≤ 5 cm in diameter) with positive nodes or large tumor (> 5 cm in diameter) with any lymph nodes status
- •Completely resected or microscopic residual disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 7.5 g/dL
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Bile acid ≤ 2.5 times ULN
- •Creatinine based on age as follows:
- •≤ 0.8 mg/dL (for patients < 5 years of age)
- •≤ 1.2 mg/dL (for patients 5-9 years of age)
- •≤ 1.5 mg/dL (for patients ≥ 10 years of age)
- •Cardiovascular
- •No severe heart disease
- •Not pregnant or nursing
- •No uncontrolled infection
- •Must have acceptable organ function for age
- 另有 11 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 3 years after study registration
次要结局
- Overall survival at 3 years after study registration
- Toxicity by NCI CTC at 3 years after study registration