NCT00049686

VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

Detailed description

OBJECTIVES: * Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes. * Determine the maximum tolerated dose of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the antitumor effects of this drug in these patients. OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
DRUG	laromustine

Timeline

• Start date: 2002-04-01
• Completion: 2008-01-01
• First posted: 2003-01-27
• Last updated: 2013-07-18

Locations

1 site across 1 country: United States