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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049686
First received: November 12, 2002
Last updated: May 12, 2011
Last verified: September 2003
History of Changes

November 12, 2002
May 12, 2011
April 2002
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Complete list of historical versions of study NCT00049686 on ClinicalTrials.gov Archive Site
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VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

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.

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.
Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
Drug: laromustine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049686
CDR0000258354, VION-CLI-029, MDA-DM-02202
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Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
National Cancer Institute (NCI)
September 2003

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