Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00003239
Collaborator
National Cancer Institute (NCI) (NIH)
90
1
1
43
2.1

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
N/A
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 :
Mar 1, 1998
Actual Primary Completion Date :
Oct 1, 2001
Actual Study Completion Date :
Oct 1, 2001

Arms and Interventions

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

    Primary Outcome Measures

    1. Number of Patients with Complete Cytogenic Response [Every 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 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

    • Study Chair: Hagop M. Kantarjian, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00003239
    Other Study ID Numbers:
    • DM97-229
    • U01CA070172
    • P30CA016672
    • MDA-DM-97229
    • MDA-FDR001791
    • NCI-T97-0105
    • CDR0000066114
    First Posted:
    Apr 30, 2004
    Last Update Posted:
    Jul 30, 2012
    Last Verified:
    Jul 1, 2012

    Study Results

    No Results Posted as of Jul 30, 2012