PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
Leukemia, Myeloid, Philadelphia-Positive

About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Philadelphia-Positive focused on measuring Chronic Myelogenous Leukemia, Interferon alpha, Roferon, Intron, Chronic Myelogenous Leukemia-Philadelphia positive
Eligibility 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.
Sites / Locations
- M. D. Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
SCH 54031
Peg Interferon Alpha-2B/PEG-Intron