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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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laromustine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No