Peginterferon Alfa-2a in Treating Patients with Essential Thrombocythemia or Polycythemia Vera
This phase II trial studies how well polyethylene glycol (peg)interferon alfa-2a works in treating patients with essential thrombocythemia or polycythemia vera. Peginterferon alfa-2a may interfere with the growth of cancer cells.
Inclusion Criteria
- Following diagnoses: * ET: Patients with platelet (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 Philadelphia (Ph) chromosome; patients with ET and lower PLT will be eligible if attributable to prior ET therapy * PV: Patients should have hemoglobin (Hb) >= 15 g/dl (except if patient is having phlebotomies done or is taking hydroxyurea) and documented past diagnosis
- Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale)
- Age greater than 18 years since disease is extremely rare in younger age group
- Total bilirubin of =< 2.0 mg/dl (except for patients with Gilbert's syndrome)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) < 3 X upper limit of normal (ULN) (or < 5 X ULN if considered due to tumor)
- 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 Institutional Review Board (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 that this is in the best interest of the patient
Exclusion Criteria
- 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: New York Heart Association (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 hepatitis B virus (HBV), human immunodeficiency virus (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00452023.
PRIMARY OBJECTIVES:
I To determine the efficacy of peginterferon alfa-2a (PEG IFN-alpha-2a) in patients with chronic myeloproliferative diseases: essential thrombocythemia (ET) and polycythemia vera (PV).
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of PEG IFN-alpha-2a in patients with these disorders.
TERTIARY OBJECTIVES:
I. To evaluate pertinent morphologic and molecular characteristics of these diseases before and during the therapy with PEG IFN-alpha-2a.
OUTLINE:
Patients receive peginterferon alfa-2a subcutaneously (SC) once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy at baseline and every 3-6 months during the first year, then if needed.
After completion of study treatment, patients are followed up every 3-6 months for 1 year, and then every 6-12 months thereafter.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLucia Masarova
- Primary IDDM03-0109
- Secondary IDsNCI-2012-01474
- ClinicalTrials.gov IDNCT00452023