VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00070538|
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: cytarabine Drug: laromustine||Phase 1|
- Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of VNP40101M.
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may receive treatment at the MTD.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies|
|Study Start Date :||June 2003|
|Primary Completion Date :||September 2004|
|Study Completion Date :||January 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070538
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4095|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|