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Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00022490
First received: August 10, 2001
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
 Drug: cytarabine
Drug: imatinib mesylate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • The Rate of Major Cytogenetic Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.


Secondary Outcome Measures:
  • The Rate of Complete Cytogenetic Response at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The Rate of Complete and Major Cytogenetic Responses at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The Rate of Minor Cytogenetic Responses at 6 and 12 Months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • The Rate of Complete Hematologic Responses at 6 and 12 Months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2001
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cytarabine
    Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
    Drug: imatinib mesylate
    Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
Detailed Description:

OBJECTIVES:

  • Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
  • Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen.
  • Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30-60 days.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)

    • Less than 15% blasts in peripheral blood or bone marrow
    • Less than 30% blasts and promyelocytes in peripheral blood or bone marrow
    • Less than 20% basophils in blood or bone marrow
    • Platelet count at least 100,000/mm^3
  • Philadelphia chromosome positive
  • No more than 6 months since initial diagnosis
  • No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma)
  • Refused allogeneic stem cell transplantation as first-line therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
  • No other serious uncontrolled medical condition
  • No history of noncompliance to medical regimens or potential unreliability

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior biologic therapy for CML

Chemotherapy:

  • No prior chemotherapy for CML except hydroxyurea
  • Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • No prior endocrine therapy for CML

Radiotherapy:

  • No prior radiotherapy for CML

Surgery:

  • Not specified

Other:

  • More than 28 days since prior investigational anticancer agents
  • Prior anagrelide hydrochloride for CML allowed
  • Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed
  • No concurrent grapefruit juice or grapefruit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022490

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Brian J. Druker, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00022490     History of Changes
Other Study ID Numbers: CDR0000068822, OHSU-NCI-4653, OHSU-1184, OHSU-HEM-01017-LX, NCI-4653
Study First Received: August 10, 2001
Results First Received: June 6, 2012
Last Updated: June 6, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cytarabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013