A Phase I Trial Using Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan and vincristine in children with relapsed hematologic malignancies
研究概览
简要总结
The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in children with relapsed or refractory hematologic malignancies. In addition we will also study the pharmacokinetics of irinotecan when given without and then with dexamethasone in each patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity and describe any antitumor effects.
详细描述
TREATMENT PLAN
Treatment This is a phase I trial of irinotecan, vincristine, and dexamethasone administered over a 2-week period. Each treatment course will be a minimum of 21 days from the first day of irinotecan. Cycles may be repeated after hematologic recovery every 21 days if in the opinion of the primary physician the patient received some benefit from the chemotherapy. Irinotecan pharmacokinetic studies for each patient will be performed with the first course of therapy. From 4 to 18 patients will be treated to determine the MTD, irinotecan pharmacokinetics, and biologic effects of this combination of chemotherapeutic agents.
Drug Dosages for Each Course Irinotecan, 20 mg/m2/day IV, Days 1-5, 8-12
**Dexamethasone Days 6-10 Vincristine 1.5 mg/m2/day IV (max 2 mg), Days 1, 8 (patients < 1 year of age or < 10kg in weight: Vincristine 0.05 mg/kg)
CNS Chemotherapy
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
- •Age < or equal to 21 years at time of study entry
- •Pathological diagnosis of a recurrent or refractory Non-Hodgkin's lymphoma, Hodgkin's disease, or acute lymphoblastic leukemia
- •ECOG performance status < or equal to 2 (or Lansky play-performance scale > or equal to 50% for children <10 years of age).
- •Has not received chemotherapy in previous 2 weeks. In the case of rapidly progressing disease, this criterion may be waived by consulting with the Principal Investigator, provided the patient has recovered from the acute effects of prior therapy.
- •Hemoglobin >8 g/dl, absolute neutrophil count >1000 /mm3 (without growth factor support), and platelet count >50,000/mm3 (without transfusion support) unless bone marrow is involved with tumor or leukemia
- •Adequate liver function (bilirubin < 1.5 x normal for age, AST and ALT < 3 x normal for age)
- •Adequate renal function (serum creatinine <3 x normal for age)
- •No active graft-versus-host disease (GVHD) or ongoing treatment for GVHD
排除标准
- •Currently receiving other cytotoxic or investigational drugs
- •Pregnant or lactating females are not eligible. Pregnancy tests must be obtained in females who are post-menarchal.
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, azole antifungals, aprepitant, or St. John's Wort is not allowed.
- •Evidence of active infection at the time of protocol entry
- •History of allergy to any of the study medications
研究组 & 干预措施
1
干预措施: Dexamethasone (Drug)
1
干预措施: Irinotecan (Drug)
1
干预措施: Vincristine (Drug)
结局指标
主要结局
Estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan and vincristine in children with relapsed hematologic malignancies
时间窗: Maximum Tolerated Dose (MTD)
次要结局
未报告次要终点