Status:
COMPLETED
Pegasys® in Patients With Myeloproliferative Diseases
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Myeloproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this treatment will also...
Detailed Description
IFN-alpha2a has been used for the treatment of a variety of disorders (such as hepatitis C). IFN-alpha2a is a drug that may affect the way infections and malignant diseases develop. Before treatment ...
Eligibility Criteria
Inclusion
- Following diagnoses: --ET: Patients with PLT \> 600 x10 9 /l documented in the past 12 months; hyperplasia of marrow megakaryocytes in the absence of identifiable cause of thrombocytosis and in the absence of Ph chromosome. Patients with ET and lower PLT will be eligible if attributable to prior ET therapy. --PV: Patients should have Hb \>/= 15g/dl (except if patient is having phlebotomies done) and documented past diagnosis.
- Performance status \</= 2 (ECOG scale).
- Age greater than 18 years since disease is extremely rare in younger age group.
- Adequate liver function: total bilirubin of \</= 2.0 mg/dl (except for patients with Gilbert's Syndrome) and AST (SGOT) or ALT (SGPT) \< 3 X ULN (or \< 5 X ULN if considered due to tumor), and renal function (serum creatinine \</= 2.0 mg/dl).
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the M.D. Anderson Cancer Center. The only acceptable consent form is the one approved by the M.D. Anderson Cancer Center IRB.
- Willingness and ability to comply with the requirements of the protocol for the duration of the study.
- Patients must have been off chemotherapy for 1 week prior to beginning Pegasys and have recovered from the toxic effects of that therapy. Patients may have received hydroxyurea or anagrelide immediately before study entry, and may continue into therapy if treating physician determines this is in the best interest of the patient.
Exclusion
- Pregnant or lactating women.
- Patients with prior history of another malignancy or concurrent malignancy, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies if the patient is disease free \>3 years.
- Patients with history of ischemic retinopathy.
- Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina.
- Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease.
- Patients with seizure disorders requiring anticonvulsant therapy.
- Patients with known infection with HBV, HIV, or other active systemic infection.
- Patients with known autoimmune disease except for rheumatoid arthritis.
- Patients with renal disease on hemodialysis.
- Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun.
- Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.
Key Trial Info
Start Date :
April 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00452023
Start Date
April 7 2005
End Date
May 26 2023
Last Update
December 11 2024
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030