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

• Status: Terminated
• Trial end date: 2003-12-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Schering-Plough
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b

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
• 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.