NCT00993044已完成1 期
A Phase I Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
This phase I study is designed to determine the maximum tolerated dose of Irinotecan given intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine, Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.
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
- 12 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients must be > 12 months and < 21 years of age at the time of study entry.
- •Weight: Patient must be more than or equal to 10 Kilograms.
- •Histological Diagnosis:
- •Patients must have had histological verification of the malignancy at some time prior to study entry.
- •All solid tumors are eligible with the exclusion of lymphomas. For patients with neuroblastoma, diagnosis based on elevated catecholamines in the urine and tumor cells on bone marrow aspirates/biopsies is acceptable.
- •For patients with germ cell tumors, diagnosis based on elevated tumor markers (serum alpha fetoprotein and/or serum beta human chorionic gonadotropin) and radiographic evidence of disease is acceptable.
- •Disease Status:
- •Disease must have failed standard therapy (therapies) or be a disease for which no standard therapy exists.
- •Patient with stable disease on other therapies are not eligible.
- •Performance Level:
- •Karnofsky > 50% for patients >16 years of age and Lansky > 50 for children < 16 years of age (Appendix I).
- •Life Expectancy: Must be > 8 weeks.
排除标准
- •Patients who have received bevacizumab and/or Irinotecan previously are ineligible. Non brain tumor patients who have previously received Temozolomide are ineligible.
- •Pregnancy or Breast-Feeding: Pregnant patients are ineligible for this study due to the known teratogenic effects of the cytotoxic agents. Pregnancy tests must be obtained in females of childbearing potential prior to enrollment.
- •Lactating women must agree not to breast-feed.
- •Males or females of reproductive age may not participate unless they have agreed to use an effective contraceptive method.
- •Patients Who Have an Uncontrolled Infection will not be eligible for enrollment until all infections are under control.
- •Clinically Significant Unrelated Systemic Illness: Patients with serious infections or significant pulmonary, hepatic, renal, or other end-organ dysfunction which in the judgment of the Principal or Co-Investigators would compromise the patient's ability to tolerate prescribed chemotherapy or are likely to interfere with the study procedures or results will not be eligible.
研究组 & 干预措施
Single Arm
Experimental
干预措施: Irinotecan (Drug)
Single Arm
Experimental
干预措施: Vincristine (Drug)
Single Arm
Experimental
干预措施: Temozolomide (Drug)
Single Arm
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 2 years
Number of participants with dose limiting toxicity events
次要结局
未报告次要终点
研究者
Leo Mascarenhas
Medical Staff/USC Faculty CWR
Children's Hospital Los Angeles
研究点 (1)
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