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VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070538
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: cytarabine Drug: laromustine Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of VNP40101M.

Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator.

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 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may receive treatment at the MTD.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
Study Start Date : June 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : January 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following:

    • Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission

      • Acute myeloid leukemia
      • Acute lymphocytic leukemia
      • Chronic myelogenous leukemia

        • In blast crisis
    • Untreated leukemia and standard therapy is refused
    • Any of the following poor-risk MDS:

      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia
  • CNS leukemia allowed



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT or AST no greater than 3 times ULN
  • Chronic hepatitis allowed


  • Creatinine no greater than 2.0 mg/dL


  • No active heart disease
  • No myocardial infarction within the past 3 months
  • No symptomatic coronary artery disease
  • No arrhythmias uncontrolled by medication
  • No uncontrolled congestive heart failure


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No persistent chronic toxic effects from prior chemotherapy greater than grade 1
  • No uncontrolled active infection

    • Infections under control and under active treatment with antibiotics allowed


Biologic therapy

  • Not specified


  • At least 48 hours since prior hydroxyurea

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
  • No other concurrent standard or investigational treatment for leukemia
  • No concurrent disulfiram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070538

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United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
Sponsors and Collaborators
Vion Pharmaceuticals
National Cancer Institute (NCI)
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
Publications of Results:
Layout table for additonal information Identifier: NCT00070538    
Other Study ID Numbers: VION-CLI-034
CDR0000334879 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: August 2008
Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
blastic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
chronic myelomonocytic leukemia
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated adult acute lymphoblastic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
Additional relevant MeSH terms:
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Hematologic Neoplasms
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs