Clinical trial NCT00037882: PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
Official title: A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia, Myeloid, Philadelphia-Positive
Keywords: Chronic Myelogenous Leukemia
Interferon alpha
Roferon
Intron
Chronic Myelogenous Leukemia-Philadelphia positive
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2002-05-27
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Razelle Kurzrock, M.D.
role: STUDY_CHAIR
References: