drugset / Trial / NCT00718757
Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2005-01
- Primary completion
- 2009-01
- Completion
- 2009-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 5 mg/m2 | Oral |
| Subject | Dexamethasone | Small molecule | 10 mg/m2 | Oral |
| Subject | Dexamethasone | Small molecule | 20 mg/m2 | Oral |
| Subject | Dexamethasone | Small molecule | 30 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 20 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 0.05 mg/kg | Intravenous |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |