PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia |
- 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 |
|---|---|
|
Experimental: SCH 54031
Peg Interferon Alpha-2B/PEG-Intron
|
Drug: PEG-Intron
Once weekly injection.
Other Names:
|
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 |
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| United States, Texas | |
| M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Razelle Kurzrock, M.D. | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00037882 History of Changes |
| Other Study ID Numbers: | DM00-150 |
| Study First Received: | May 24, 2002 |
| Last Updated: | July 31, 2012 |
| 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:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Peginterferon alfa-2b Reaferon |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013