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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003239 |
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 II |
| Study Type: | Interventional |
| Study Design: | 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) |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 1998 |
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 |
| Genders Eligible for Study: | Both |
| 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 specifed
Contacts and Locations| 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
| Study ID Numbers: | CDR0000066114, MDA-DM-97229, MDA-FDR001791, NCI-T97-0105 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003239 History of Changes |
| Health Authority: | United States: Federal Government |
|
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
|
Antimetabolites Philadelphia Chromosome Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Hematologic Diseases Homoharringtonine Interferons Myeloproliferative Disorders Leukemia, Myeloid |
Leukemia, Myeloid, Chronic-Phase Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Interferon Alfa-2a Cytarabine |
|
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Chronic-Phase Leukemia Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Cytarabine Interferon-alpha |
Neoplasms by Histologic Type Hematologic Diseases Growth Substances Interferons Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Interferon Alfa-2a Bone Marrow Diseases |
