Pegasys® in Patients With Myeloproliferative Diseases - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Hoffmann-La Roche
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00452023

Purpose

The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with essential thrombocytosis (ET), polycythemia vera (PV), agnogenic myeloid metaplasia/myelofibrosis (AMM/MF), or Philadelphia chromosome-negative chronic myeloid leukemia (Ph-negative CML). The safety of this treatment will also be studied.

Condition	Intervention	Phase
Myeloproliferative Disorders	Drug: IFN-alpha2a	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	PEG IFN-alpha2a (Pegasys®) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Efficacy of PEG IFN-a2a in patients with chronic myeloproliferative diseases: ET and PV. [ Time Frame: Every other week for 2 months, then once every 1 or 2 months for a year, then every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	April 2005
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IFN-alpha2a: Experimental	Drug: IFN-alpha2a 90 microgram (mcg) injection under the skin once a week

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 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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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: 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452023

Contacts

Contact: Srdan Verstovsek, MD

713-745-3429

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Srdan Verstovsek, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Hoffmann-La Roche

Investigators

Principal Investigator:

Srdan Verstovsek, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Srdan Verstovsek, MD / Associate Professor )
Study ID Numbers:	DM03-0109
Study First Received:	March 22, 2007
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00452023 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Myeloproliferative Disorders
Essential Thrombocythemia
Polycythemia Vera
Pegasys

IFN-alpha2a
Pegylated-Interferon Alpha-2A
PEG-IFNa-2a

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia
Pathologic Processes
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Interferon-alpha
Neoplasms by Histologic Type
Disease
Hematologic Diseases

Growth Substances
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Peginterferon alfa-2a
Interferon Alfa-2a
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 08, 2010