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


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Leukemia

General leukemia; Leukemia cancer 




Clinical Trial: VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

This study is no longer recruiting patients.

Sponsored by: Vion Pharmaceuticals
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
acute leukemia
atypical chronic myeloid leukemia
chronic leukemia
Hairy Cell Leukemia
myelodysplastic and myeloproliferative disease
Prolymphocytic Leukemia
 Drug: VNP40101M
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of VNP40101M in Patients With Relapsed or Refractory Leukemia or Poor-Risk Myelodysplastic Syndromes

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

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

Surgery

  • Not specified

Other

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

Location Information


Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4095,  United States

Study chairs or principal investigators

Mario Sznol, MD,  Study Chair,  Vion Pharmaceuticals   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000258354; VION-CLI-029; MDA-DM-02202
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049686
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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December 3, 2009



Page Updated: May 11, 2006
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