VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

November 12, 2002

Last Updated Date

December 13, 2008

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00049686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

Official Title ^ICMJE

A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

Detailed Description

OBJECTIVES:

Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes.
Determine the maximum tolerated dose of this drug in these patients.
Determine the pharmacokinetics of this drug in these patients.
Determine the antitumor effects of this drug in these patients.

OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Drug: laromustine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR
Poor-risk myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 3 times ULN

Renal

Creatinine no greater than 2.0 mg/dL

Cardiovascular

No myocardial infarction within the past 3 months
No symptomatic coronary artery disease
No uncontrolled arrhythmia
No uncontrolled congestive heart failure

Other

No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior biologic therapy allowed

Chemotherapy

At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease
At least 48 hours since prior hydroxyurea

Endocrine therapy

Not specified

Radiotherapy

Prior radiotherapy allowed

Surgery

Not specified

Other

No other concurrent standard or investigational treatment for leukemia
No concurrent disulfiram

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00049686

Responsible Party

Study ID Numbers ^ICMJE

CDR0000258354, VION-CLI-029, MDA-DM-02202

Study Sponsor ^ICMJE

Vion Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Mario Sznol, MD

Vion Pharmaceuticals

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP