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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00304005
Other study ID # VION-CLI-041
Secondary ID CDR0000465217MDA
Status Completed
Phase Phase 1/Phase 2
First received March 15, 2006
Last updated July 17, 2013
Start date July 2005
Est. completion date August 2008

Study information

Verified date August 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 2008
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
laromustine


Locations

Country Name City State
United States M.D. Anderson Cancer Center at University of Texas Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Vion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose Yes
Primary Toxicity Yes
Primary Efficacy No
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