Pegasys® in Patients With Myeloproliferative Diseases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00452023
First received: March 22, 2007
Last updated: November 14, 2013
Last verified: November 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Number of Patients with Complete or Partial Response [ Time Frame: 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
Experimental: IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week.
Drug: IFN-alpha2a
Starting dose 90 microgram (mcg) injection under the skin once a week
Other Names:
  • Pegylated-Interferon Alpha-2A
  • PEG-IFNa-2a
  • Pegasys

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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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

  1. 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.
  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:

  1. Pregnant or lactating women.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Hoffmann-La Roche
Investigators
Principal Investigator: Srdan Verstovsek, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00452023     History of Changes
Other Study ID Numbers: DM03-0109
Study First Received: March 22, 2007
Last Updated: November 14, 2013
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:
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014