drugset / Trial / NCT00070538
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
Open-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
Timeline
- Start
- 2003-06
- Primary completion
- 2004-09
- Completion
- 2008-01
Publications
- Results Giles F, Verstovsek S, Thomas D, Gerson S, Cortes J, Faderl S, Ferrajoli A, Ravandi F, Kornblau S, Garcia-Manero G, Jabbour E, O'Brien S, Karsten V, Cahill A, Yee K, Albitar M, Sznol M, Kantarjian H. Phase I study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, combined with cytarabine in patients with refractory leukemia. Clin Cancer Res. 2005 Nov 1;11(21):7817-24. doi: 10.1158/1078-0432.CCR-05-1070.
- Results Giles FJ, Verstovsek S, Cortes J, et al.: Phase I study of VNP40101M (101M) and AraC in patients (pts) with refractory leukemia. [Abstract] J Clin Oncol 22 (14 Suppl): A-6617, 586s, 2004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | laromustine | Other / unclassified | 200 mg/m2 | Intravenous |
| 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 | 1500 mg/m2 | Intravenous |