VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT00049686|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: laromustine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies|
|Study Start Date :||April 2002|
|Actual Study Completion Date :||January 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049686
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4095|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|