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

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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

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

Genetics Home Reference related topics: Chronic myeloid leukemia

MedlinePlus related topics: Chronic Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine Interferon Omacetaxine mepesuccinate Interferon Alfa-2a

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders

U.S. FDA Resources

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 :

Number of Patients with Complete Cytogenic Response [ Time Frame: Every 3 months ]

Eligibility Criteria

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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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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

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 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 )
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

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