Lymphoma Clinical Trial
Official title:
A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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