Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2005-04-07
2023-05-26
Brief Summary
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Detailed Description
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Before treatment starts, you will have blood (around 2 teaspoons) and bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. These samples will be used for tests to confirm the diagnosis of the disease. Women who are able to have children must have a negative blood pregnancy test.
During treatment, you will receive IFN-alpha2a as an injection under the skin once a week. You (or your caregiver) will be taught how to give the injections, and you will receive treatment on an outpatient basis.
Treatment will continue (injections once a week) as long as the disease does not get worse.
If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
During treatment you will have blood (around 1 teaspoon) collected every other week for 2 months, then once every 1 or 2 months for a year, then every 3 months. You will also have bone marrow samples collected every 3 to 6 months during the first year of treatment. After the first year of treatment, bone marrow samples will be collected only when your doctor feels they are needed. The blood and bone marrow samples will be used for tests to check on the response to therapy.
This is an investigational study. IFN-alpha2a has been approved by the FDA for the treatment of hepatitis C and is commercially available. However the use of IFN-alpha2a in this study is investigational. The commercial prepartion of IFN-alpha2a(Pegasys) will be used in this study. Up to 280 participants will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IFN-alpha2a 90 Microgram (mcg) weekly
Starting dose 90 microgram (mcg) injection under the skin once a week.
IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
IFN-alpha2a 450 Microgram (mcg) weekly
Starting dose 450 microgram (mcg) injection under the skin once a week.
IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
IFN-alpha2a 360 Microgram (mcg) weekly
Starting dose 360 microgram (mcg) injection under the skin once a week.
IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
IFN-alpha2a 270 Microgram (mcg) weekly
Starting dose 270 microgram (mcg) injection under the skin once a week.
IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
IFN-alpha2a 180 Microgram (mcg) weekly
Starting dose 180 microgram (mcg) injection under the skin once a week.
IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
Interventions
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IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Performance status \</= 2 (ECOG scale).
3. Age greater than 18 years since disease is extremely rare in younger age group.
4. 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).
5. 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.
6. Willingness and ability to comply with the requirements of the protocol for the duration of the study.
7. 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 Criteria
2. 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.
3. Patients with history of ischemic retinopathy.
4. Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina.
5. 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.
6. Patients with seizure disorders requiring anticonvulsant therapy.
7. Patients with known infection with HBV, HIV, or other active systemic infection.
8. Patients with known autoimmune disease except for rheumatoid arthritis.
9. Patients with renal disease on hemodialysis.
10. 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.
11. Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lucia Masarova, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Masarova L, Yin CC, Cortes JE, Konopleva M, Borthakur G, Newberry KJ, Kantarjian HM, Bueso-Ramos CE, Verstovsek S. Histomorphological responses after therapy with pegylated interferon alpha-2a in patients with essential thrombocythemia (ET) and polycythemia vera (PV). Exp Hematol Oncol. 2017 Nov 9;6:30. doi: 10.1186/s40164-017-0090-5. eCollection 2017.
Masarova L, Patel KP, Newberry KJ, Cortes J, Borthakur G, Konopleva M, Estrov Z, Kantarjian H, Verstovsek S. Pegylated interferon alfa-2a in patients with essential thrombocythaemia or polycythaemia vera: a post-hoc, median 83 month follow-up of an open-label, phase 2 trial. Lancet Haematol. 2017 Apr;4(4):e165-e175. doi: 10.1016/S2352-3026(17)30030-3. Epub 2017 Mar 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2012-01474
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM03-0109
Identifier Type: -
Identifier Source: org_study_id