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Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Leukemia | Biological: Recombinant Interferon Alfa Drug: Cytarabine Drug: Omacetaxine Mepesuccinate | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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) |
- Number of Patients with Complete Cytogenic Response [ Time Frame: Every 3 months ]
| Enrollment: | 90 |
| Study Start Date: | March 1998 |
| Study Completion Date: | October 2001 |
| Primary Completion Date: | October 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Drug: Cytarabine
Daily by subcutaneous injection.
Other Names:
Drug: Omacetaxine Mepesuccinate
Homoharringtonine is administered by continuous infusion on days 1-5.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003239
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Hagop M. Kantarjian, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003239 History of Changes |
| 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 ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 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:
|
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 Homoharringtonine Interferons Cytarabine Harringtonines Interferon-alpha |
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 Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017