drugset / Trial / NCT00655395
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
Non-randomizedSingle-groupOpen-labelTreatment
Summary
* The purpose of the Phase I portion of this study is to evaluate the safety of this combination of medications and to determine the appropriate dose of VNP40101M to be used in combination with infusional cytarabine (araC) in elderly patients with Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS). * The purpose of the Phase II portion of the study is to evaluate the effectiveness (overall response rate) for patients treated with VNP40101M and infusional cytarabine induction therapy.
Timeline
- Start
- 2008-03
- Primary completion
- 2010-04
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | laromustine | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | laromustine | Other / unclassified | 400 mg/m2 | Intravenous |
| Subject | laromustine | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | laromustine | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | — |