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

Sponsor

Vion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00304005

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Drug: laromustine	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose []
Toxicity []
Efficacy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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