search
Back to results

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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
laromustine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M.D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Maximum tolerated dose
Toxicity
Efficacy

Secondary Outcome Measures

Full Information

First Posted
March 15, 2006
Last Updated
July 17, 2013
Sponsor
Vion Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00304005
Brief Title
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
Official Title
A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
laromustine
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Title
Toxicity
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny L. Johnson, RN, MSN
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs