VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

Phase 1

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT00070538
• Lead Sponsor: Vion Pharmaceuticals

Brief 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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-10-03
• Study First Submitted QC: 2003-10-06
• Study First Posted: 2003-10-07
• Primary Completion: 2004-09
• Study Completion: 2008-01
• Status Verified: 2008-08
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States