VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following hematologic malignancies:

• Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)

• CLL in transformation allowed

• Richter syndrome

• Other refractory lymphoproliferative diseases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Creatinine ≤ 2.0 mg/dL

• Renal dysfunction due to organ infiltration by disease allowed

• AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)

• Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No symptomatic coronary artery disease

• No arrhythmia not controlled by medication

• No uncontrolled, symptomatic congestive heart failure

• No myocardial infarction within the past 3 months

• No other uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease

• No other concurrent standard or investigational treatment for this cancer

• No other concurrent cytotoxic investigational drugs

• No concurrent disulfiram