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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Schering-Plough
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00037882

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

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

Resource links provided by NLM:

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

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

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	February 2001
Study Completion Date:	December 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SCH 54031: Experimental Peg Interferon Alpha-2B/PEG-Intron	Drug: PEG-Intron Once weekly injection.

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

Inclusion 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.

Exclusion Criteria:

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

Investigators

Study Chair:

Razelle Kurzrock, M.D.

UT MD Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Razelle Kurzrock, M.D. / Professor )
Study ID Numbers:	DM00-150
Study First Received:	May 24, 2002
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00037882 History of Changes
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

Additional relevant MeSH terms:

Interferon-alpha
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Angiogenesis Inhibitors

Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Peginterferon alfa-2b
Growth Inhibitors
Angiogenesis Modulating Agents
Bone Marrow Diseases
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on November 09, 2009