VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
- Phase II: Patients receive VNP40101M at the MTD determined in phase I.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304005
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Bonny L. Johnson, RN, MSN||Vion Pharmaceuticals|