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Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
This study has been completed.
First Received: November 12, 2002   Last Updated: April 4, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049192
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in treating patients who have chronic myelogenous leukemia that has not responded to previous treatment with imatinib mesylate.


Condition Intervention Phase
Leukemia
Biological: oblimersen sodium
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of G3139 (Genasense, NSC #683428 IND #58842) + Imatinib Mesylate (Gleevec, STI571) in Patients With Imatinib-Resistant Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the cytogenetic response rate of patients with imatinib mesylate-resistant chronic myelogenous leukemia treated with oblimersen and imatinib mesylate.
  • Determine the hematologic and molecular response rate and duration of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or twice daily. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without a hematologic response after 2 courses go off study. Patients with complete or partial response after 4 courses may continue to receive oral imatinib mesylate daily.

Patients in cohort 2 receive an escalated dose of oblimersen; if well tolerated, subsequent cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate. If oblimersen is not well tolerated in cohort 2, subsequent cohorts receive the original dose of oblimersen with an escalated dose of imatinib mesylate. The first 6 patients accrued continue to receive the original dose (dose taken prior to study) of imatinib mesylate throughout the study.

Patients are followed monthly for 3 months and then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 6 months.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic myelogenous leukemia in chronic phase
  • Refractory to prior imatinib mesylate by the following criteria:

    • At least 400 mg/day for more than 8 weeks without a complete hematologic response or more than 6 months without a major cytogenetic response
    • No evidence of disease progression to accelerated or blast phases
  • Must have received stable dose (at least 600 mg/day) of imatinib mesylate for at least 4 weeks without grade 2 or greater toxic effects
  • If Philadelphia chromosome t(9;22) or a variant translocation is not detectable, then patients must meet 1 of the following:

    • Polymerase chain reaction positive fusion transcripts for BCR/ABL
    • BCR/ABL translocation present by fluorescence in situ hybridization
  • Must also be registered on CLB-9665 and CLB-29801

PATIENT CHARACTERISTICS:

Age

  • 15 and over

Performance status

  • Not specified

Life expectancy

  • At least 2 years

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 2 mg/dL
  • AST no greater than 1.5 times upper limit of normal (ULN)
  • PTT no greater than 1.5 times ULN

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

  • No uncontrolled cardiovascular disease

Pulmonary

  • No pulmonary disease that would preclude study participation

Other

  • No other concurrently active malignancy except nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30% risk of relapse within 1 year)
  • No diabetes
  • No infection
  • No other serious illness that would limit life expectancy
  • No psychiatric condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior stem cell transplantation
  • At least 4 weeks since prior interferon

Chemotherapy

  • At least 4 weeks since prior hydroxyurea, homoharringtonine, or cytarabine
  • No other prior antineoplastic agents (e.g., busulfan)
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent hormones except for steroids for adrenal failure or drug-related rash or hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens for osteopenia)

Radiotherapy

  • No concurrent palliative radiotherapy

Surgery

  • No concurrent surgical splenectomy except for traumatic injury, unresponsive infarction, emergency management, or splenic hemorrhage

Other

  • At least 4 weeks since prior investigational agents
  • At least 4 weeks since prior anagrelide
  • No concurrent oral anticoagulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049192

  Hide Study Locations
Locations
United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
United States, District of Columbia
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nevada
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302-2000
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States, 28025
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28503-1678
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805-9913
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75219
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Meir Wetzler, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000257816, CALGB-10107
Study First Received: November 12, 2002
Last Updated: April 4, 2009
ClinicalTrials.gov Identifier: NCT00049192     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Philadelphia chromosome positive chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 25, 2009