Azacitidine in Treating Patients With Myelofibrosis

NCT ID: NCT00381693

Last Updated: 2011-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.

Detailed Description

OBJECTIVES:

Primary

• Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia.
• Evaluate the safety of azacitidine in these patients. Secondary
• Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine.
• Assess the effects of study treatment on constitutional symptoms in these patients.
• Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

Chronic Myeloproliferative Disorders; Secondary Myelofibrosis

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

azacitidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes:

• Agnogenic myeloid metaplasia
• Post-polycythemic myeloid metaplasia
• Post-thrombocythemic myeloid metaplasia
• Evaluable and symptomatic disease, defined as 1 of the following:

• Anemia (hemoglobin < 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks)
• Treatment required* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: *Subjective but painful enough to mandate intervention
• Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow)

• Previous demonstration of a lack of this translocation (at any point) is sufficient
• No advanced malignant hepatic tumors

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 50,000/mm³
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease)
• AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No baseline peripheral or autonomic neuropathy ≥ grade 2
• No condition, including the presence of laboratory abnormalities, that would preclude study compliance
• No hypersensitivity to mannitol or azacitidine
• Not incarcerated in a municipality (i.e., county, state, or federal prison)

PRIOR CONCURRENT THERAPY:

• At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents
• At least 14 days since prior systemic corticosteroids
• At least 14 days since prior investigational agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Cancer Center

Principal Investigators

Ruben A. Mesa, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

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MC058D

Identifier Type: OTHER

Identifier Source: secondary_id

05-004297

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000503972

Identifier Type: -

Identifier Source: org_study_id