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VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00354276
Recruitment Status : Unknown
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : January 10, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: laromustine Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate in older patients with poor-risk, de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy.

Secondary

  • Determine the probability of overall survival, leukemia-free survival, and progression-free survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

  • Induction therapy: Patients receive VNP40101M IV over 60 minutes on day 1 (course 1). Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60. Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy.
  • Consolidation therapy: Beginning between days 45-90, patients receive cytarabine IV continuously over 5 days (course 1). Patients may receive a second course of cytarabine at the discretion of the investigator.

After completion of study treatment, patients are followed periodically for up to 36 months.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia
Study Start Date : May 2006
Estimated Primary Completion Date : December 2008





Primary Outcome Measures :
  1. Complete response rate

Secondary Outcome Measures :
  1. Leukemia-free survival


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed de novo acute myeloid leukemia (AML)

    • No acute promyelocytic leukemia [t(15;17)]
    • No favorable cytogenetics, including t(15;17), t(8;21), or inv 16
    • No secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS] or myeloproliferative disease), or history of prior chemotherapy or radiation for a disease other than AML
  • Must have ≥ 1 of the following poor-risk features:

    • Any of the following unfavorable cytogenetics:

      • Del (5q)/-5q
      • -7/del(7q)
      • Abnormal 3q, 9q, 11q, 20q, 21q, or 17p
      • t(6;9)
      • t(9;22)
      • Trisomy 8
      • Complex karyotypes (≥ 3 unrelated abnormalities)
    • At least 70 years of age
    • ECOG performance status (PS) of 2
    • Cardiac dysfunction* that would limit the use of anthracycline therapy, as defined by any of the following:

      • Ejection fraction ≤ 50%
      • History of significant coronary artery disease, defined as ≥ 1 vessel stenosis requiring medical treatment, stent placement, or surgical bypass graft
      • History of congestive heart failure or myocardial infarction
      • Significant arrhythmia, including any of the following:

        • Atrial flutter (excluding atrial fibrillation)
        • Sick sinus syndrome
        • Ventricular arrhythmia
      • Heart valve disease

        • Mitral valve prolapse allowed
      • Other heart disease, at the discretion of the principal investigator
    • Pulmonary dysfunction not related to AML, defined by 1 of the following:

      • DLCO and/or FEV_1 < 80% and ≥ 50% normal range
      • Dyspnea on slight activity or at rest
      • Requires oxygen
    • Hepatic dysfunction related to chronic hepatitis or liver cirrhosis
    • Other organ dysfunction or comorbidity that precludes standard cytotoxic induction treatment (e.g., "3+7"), at the discretion of the principal investigator NOTE: *Patients with a history of heart disease as defined above must be on appropriate medication and have their disease under control
  • No known CNS disease

PATIENT CHARACTERISTICS:

  • ECOG PS 0-2
  • AST and ALT ≤ 5 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No active, uncontrolled infection

    • Patients with an infection who are under active treatment with antibiotics and whose infections are controlled are eligible
    • Chronic hepatitis allowed
  • No clinical evidence of ongoing second malignancy unrelated to AML or MDS
  • No evidence of left bundle branch block on screening ECG
  • No obligate use of cardiac pacemaker or atrial fibrillation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 24 hours since prior metronidazole
  • No prior low-dose, single-agent, cytotoxic chemotherapy (e.g., cytarabine, decitabine, or azacitidine)
  • No concurrent disulfiram
  • No other concurrent standard or investigational therapy for AML except for the following:

    • Concurrent hydroxyurea to control rising white blood cell counts

      • Dosage must be 4-6 grams daily for up to 4 days
    • Concurrent leukapheresis to control blast cell counts

      • Must be completed within the first 5 days of study therapy
      • No more than 2 procedures per day or 4 procedures total
    • Investigational supportive care agents (e.g., antimicrobials or antifungal agents), at the discretion of the protocol sponsor

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 ClinicalTrials.gov identifier (NCT number): NCT00354276


Locations
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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
France
Hopital Haut Leveque
Pessac, France, 33604
United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Vion Pharmaceuticals
Investigators
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OverallOfficial: Bonny L. Johnson, RN, MSN Vion Pharmaceuticals

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ClinicalTrials.gov Identifier: NCT00354276    
Obsolete Identifiers: NCT00389623
Other Study ID Numbers: CDR0000492755
VION-CLI-043
EUDRACT-2006-001853-89
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: May 2009
Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(16;16)(p13;q22)
untreated adult acute myeloid leukemia
adult acute myelomonocytic leukemia (M4)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute eosinophilic leukemia
adult acute minimally differentiated myeloid leukemia (M0)
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs