A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.
II. Determine the toxic effects and pharmacokinetics of this drug in these patients.
III. Determine the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
- •Neuroblastoma
- •Osteosarcoma
- •Ewing's sarcoma
- •Rhabdomyosarcoma
- •Wilms tumor
- •CNS tumors
- •Histological verification not required for brainstem tumors
- •No acute leukemia
- •Not eligible for higher priority COG phase I/II study
- •Performance status - Karnofsky 50-100% (over age 10)
- •Performance status - Lansky 50-100% (age 10 and under)
- •At least 2 months
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 75,000/mm^3 (transfusion independent)
- •Hemoglobin at least 8.0 g/dL (transfusion allowed)
- •No granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow involvement
- •Bilirubin no greater than 1.5 times normal
- •SGPT no greater than 5 times normal
- •Albumin at least 2 g/dL
- •Creatinine no greater than 1.5 times normal
- •Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal
- •Shortening fraction at least 27% by echocardiogram
- •Ejection fraction at least 50% by MUGA
- •Stable neurologic deficits within the past 2 weeks for patients with CNS tumors
- •CNS toxicity less than grade 2
- •No active graft-versus-host disease
- •No active uncontrolled infection or other serious medical condition
- •No uncontrolled diabetes mellitus
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •At least 7 days since prior biologic therapy and recovered
- •Prior bone marrow or stem cell transplantation allowed
- •At least 6 months since prior allogeneic stem cell transplantation
- •At least 1 week since prior growth factors
- •No concurrent immunomodulating agents
- •At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- •No other concurrent chemotherapy
- •Concurrent dexamethasone for CNS tumors allowed if on stable dose for at least 2 weeks prior to study
- •Concurrent corticosteroids allowed only for increased intracranial pressure in patients with CNS tumors
- •At least 2 weeks since prior local (small port) palliative radiotherapy
- •At least 6 months since prior radiotherapy to 50% or more of the pelvis
- •At least 6 months since prior craniospinal radiotherapy
- •At least 6 weeks since other prior substantial bone marrow radiotherapy
- •Recovered from prior radiotherapy
- •No concurrent radiotherapy except localized palliative radiotherapy
- •No concurrent anticonvulsants
排除标准
- 未提供
研究组 & 干预措施
Treatment (alvocidib)
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: alvocidib (Drug)
Treatment (alvocidib)
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
时间窗: Day 21
次要结局
未报告次要终点