PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron - Full Text View

Purpose

The purpose of this study is to determine if PEG-Intron is better tolerated and more efficacious than standard interferons (Roferon, Intron) in patients with Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously received standard interferon therapy and have been intolerant, resistant, or have relapsed disease.

Condition	Intervention	Phase
Leukemia, Myeloid, Philadelphia-Positive	Drug: PEG-Intron	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia

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

Estimated Enrollment:	30
Study Start Date:	February 2001
Estimated Study Completion Date:	December 2003

Detailed Description:

It has been shown that patients who experience complete hematologic or at least a partial cytogenetic response to interferon will have improved survival times. In addition, evidence exists that even patients who do not demonstrate a cytogenetic response to interferon treatment can still benefit from treatment, in terms of survival, compared to patients not treated with interferon. This indicates that if a patient is better able to tolerate interferon, he or she may have improved survival even without cytogenetic response. Preliminary studies suggest that PEG-Intron is more convenient for patients (administered once weekly rather than daily), is better tolerated than interferon, and can produce hematologic remission in interferon-a resistant patients. Phase II studies are needed to ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such patients.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Chronic phase CML, documented by the presence of Philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or PCR.
WBC >/= 3000/ul </=100,000/ul.
Patients must have received prior interferon therapy & proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
Patient must have ECOG status of 0, 1, or 2
Labs: SGOT/SGPT<2xULN; serum bilirubin<2xULN; serum creatinine <2.0mg/dl
Recovered from effects of major surgery
Life expectancy > 12 wks.
Signed informed consent.
Women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of PEG-Intron & use effective contraception during the study.
NO accelerated Phase CML patients with peripheral blood: blasts>/=15%, basophils>/=20%, blasts+promyelocytes>/=30%, platelets<100,000/ul (unrelated to therapy). Blastic phase CML:>/=30% in peripheral blood/bone marrow.
NO patients with known hypersensitivity to interferon-a.
NO severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (NYHA classification III/IV).
NO history of neuropsychiatric disorder requiring hospitalization.
NO patients requiring therapy for refractory thyroid dysfunction
NO patients with uncontrolled diabetes mellitus.
NO patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
NO pregnant or lactating patients.
NO patients known to be actively using alcohol or drugs
NO patients receiving any experimental therapy within 30 days of enrollment in study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037882

Locations


United States, Texas
	M. D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Schering-Plough

More Information

Public website for M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	DM00-150
First Received:	May 24, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00037882
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myelogenous Leukemia

Interferon alpha

Roferon

Intron

Chronic Myelogenous Leukemia-Philadelphia positive

Study placed in the following topic categories:

Interferon-alpha

Leukemia

Chronic myelogenous leukemia

Hematologic Diseases

Interferons

Peginterferon alfa-2b

Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid

Interferon Alfa-2a

Bone Marrow Diseases

Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Schering-Plough
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00037882