PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Schering-Plough
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00303290

Purpose

The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Chronic Myeloid Leukemia	Drug: Peg Interferon Alpha 2b (Peg Intron) Drug: Ara-C (cytosine arabinoside)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine hydrochloride Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferon alfa-n1 Cytarabine Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete Cytogenetic Response Rate after One Year on Therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2000
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PEG-Intron + ARA-C: Experimental	Drug: Peg Interferon Alpha 2b (Peg Intron) 4.5 micrograms/kg once a week Drug: Ara-C (cytosine arabinoside) 10 mg under the skin daily

Detailed Description:

During treatment, patients will have blood tests every 1 to 4 weeks. Bone marrow samples will be taken every 3 months during the first year and then every 3 to 6 months. Bone marrow sampling is done with a large needle.

During treatment, patients will receive PEG-Intron once a week. Patients will also receive Ara-C injections under the skin. Patients will be taught to inject themselves, or a family member or friend can be taught how to give injections. Treatment will be given in the outpatient clinic at M. D. Anderson or in a clinic close to the patient.

Patients will receive treatment as long as it is helping to control the disease. Treatment will go on for about 5 to 7 years. Individual treatments will last about 4 hours.

This is an investigational study. The FDA has approved PEG-Intron only for research studies. About 100 patients will take part in this study. This study is being conducted only by M.D. Anderson.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients age 12 years or older with a diagnosis of Ph-positive or bcr-positive CML in early chronic phase CML (diagnosis < 12 months).
Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance status of 2 or less on Zubrod scale.
Patients under age 55 years should have HLA A,B,C, and DR typing performed on themselves and their siblings. Patients under age 20 years and patients with late chronic phase, accelerated phase or blastic phase will be offered allogeneic bone marrow transplantation from a matched sibling as the first priority.

Exclusion Criteria:

Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or lactating females
Women of pregnancy potential must practice birth control methods because of the potential risk of fetal teratogenecity with these agents.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Definition of CML Phases: a. Early chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c. Accelerated phase CML: presence of any of the following features: - Peripheral or marrow blasts 15% or more - Peripheral or marrow basophils 20% or more - Thrombocytopenia < 100 x 109L unrelated to therapy - Documented extramedullary blastic disease outside liver or spleen
Continuation of # 4 d. Clonal evolution defined as the presence of additional clones other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-A therapy (22,23). Hence these patients will be eligible if no other therapy (22,23). Hence these patients will be eligible if no other accelerated phase signs are present.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303290

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

Schering-Plough

Investigators

Principal Investigator:

Jorge E Cortes, MD

The University of Texas N.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Jorge Cortes, MD / Professor )
Study ID Numbers:	DM99-127
Study First Received:	March 15, 2006
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00303290 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Early Chronic Phase CML
Peg Interferon Alpha 2b
Peg Intron
Ara-C
Cytosine Arabinoside

Additional relevant MeSH terms:

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
Growth Inhibitors
Angiogenesis Modulating Agents
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
Peginterferon alfa-2b
Interferon Alfa-2a
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 09, 2009