PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
- Conditions
- Leukemia, Myeloid, Philadelphia-Positive
- Interventions
- Drug: PEG-Intron
- Registration Number
- NCT00037882
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCH 54031 PEG-Intron Peg Interferon Alpha-2B/PEG-Intron
- Primary Outcome Measures
Name Time Method Efficacy 2 Years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States