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Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous 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: NCT00003239
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : July 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and homoharringtonine and biological therapy with interferon alfa in treating patients with chronic phase chronic myelogenous leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Biological: Recombinant Interferon Alfa Drug: Cytarabine Drug: Omacetaxine Mepesuccinate Phase 2

Detailed Description:

OBJECTIVES: I. Determine the effectiveness of low dose cytarabine, homoharringtonine, and interferon alfa in stimulating a complete cytogenic response in patients with Philadelphia chromosome positive early chronic phase chronic myelogenous leukemia. II. Evaluate the duration of the cytogenic response in these patients after this treatment. III. Determine differential success rates and analyze results by prognostic subsets (e.g., risk group, splenomegaly, thrombocytosis, age, etc.) in this patient population.

OUTLINE: Patients receive debulking therapy consisting of hydroxyurea until blood count is at proper level. Patients then receive interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5. Treatment continues for 5-7 years in the absence of unacceptable toxicity or disease progression (accelerated or blastic phase CML). If complete remission is achieved, peripheral blood stem cells are collected. Patients are followed every 3 months for the first year and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Alpha Interferon (IFN-A), Low-Dose Cytosine Arabinoside (ARA-C), and Homoharringtonine (HHT)
Study Start Date : March 1998
Actual Primary Completion Date : October 2001
Actual Study Completion Date : October 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy with Cytarabine + Homoharringtonine
Interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5.
 Biological: Recombinant Interferon Alfa
Daily by subcutaneous injection.
Other Names:
  • Interferon Alpha 2-A
  • Roferon-A

Drug: Cytarabine
Daily by subcutaneous injection.
Other Names:
  • Ara-C
  • DepotCyt
  • Cytosine Arabinosine Hydrochloride

Drug: Omacetaxine Mepesuccinate
Homoharringtonine is administered by continuous infusion on days 1-5.
Other Names:
  • CGX-635-CML-202
  • HHT
  • Homoharringtonine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients with Complete Cytogenic Response [ Time Frame: Every 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Cytologically confirmed early chronic phase chronic myelogenous leukemia (CML) Diagnosed within 12 months Philadelphia chromosome positive OR bcr positive No late chronic phase, accelerated phase, or blastic phase CML

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: No severe heart disease Other: No psychoses Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Less than 1 month of prior interferon alfa Chemotherapy: Less than 1 month of prior cytarabine Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Contacts and Locations
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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): NCT00003239


Locations
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United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Hagop M. Kantarjian, MD M.D. Anderson Cancer Center
More Information
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Additional Information:
UT MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003239    
Other Study ID Numbers: DM97-229
U01CA070172 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-97229 ( Other Identifier: UT MD Anderson Cancer Center )
MDA-FDR001791
NCI-T97-0105
CDR0000066114 ( Registry Identifier: NCI PDQ )
First Posted: April 30, 2004    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Homoharringtonine
HHT
cephalotaxus alkaloid
cytarabine
 Interferon Alpha 2-A
Roferon-A
Ara-C
DepotCyt
Cytosine Arabinosine Hydrochloride
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Cytarabine
Interferon-alpha
Interferon alpha-2
 Homoharringtonine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Synthesis Inhibitors
Enzyme Inhibitors