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

NCT ID: NCT00304005

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-08-31

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.

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.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

laromustine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bonny L. Johnson, RN, MSN

Role: STUDY_CHAIR

Vion Pharmaceuticals

Locations

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

CDR0000465217

Identifier Type: REGISTRY

Identifier Source: secondary_id

MDA-2005-0249

Identifier Type: -

Identifier Source: secondary_id

VION-CLI-041

Identifier Type: -

Identifier Source: org_study_id