Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

NCT ID: NCT00630994

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-04-30

Brief Summary

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

PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.

Detailed Description

OBJECTIVES:

• Determine the efficacy and safety of low-dose decitabine in patients with symptomatic primary myelofibrosis (PMF) or post essential thrombocythemic (ET) or polycythemic vera (PV) myelofibrosis.
• Analyze the ability of this drug to decrease pathologic angiogenesis and other stromal reactive features intrinsic to PMF or post ET/PV myelofibrosis.

OUTLINE: Patients receive low-dose decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial remission, complete remission, or clinical improvement may receive up to 12 courses of decitabine in the absence of disease progression or unacceptable toxicity.

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

Conditions

Chronic Myeloproliferative Disorders; Secondary Myelofibrosis

Keywords

primary myelofibrosis; secondary myelofibrosis; essential thrombocythemia; polycythemia vera

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dacogen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis

• Reticulin fibrosis ≥ grade 1
• Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following:

• Anemia, defined as hemoglobin < 11 g/dL or erythrocyte transfusion dependence
• Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized)
• Severe, disease-related constitutional symptoms, including ≥ 1 of the following:

• Severe night sweats
• Fevers
• Weight loss
• Bone pain
• Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation

PATIENT CHARACTERISTICS:

• Eastern Co-operative Oncology Group (ECOG) performance status 0-3
• Absolute neutrophil count (ANC) ≥ 1,000/mm³
• Platelet count ≥ 50,000/mm³
• Creatinine ≤ 2.0 mg/dL
• Direct or total bilirubin ≤ 2.0 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Not incarcerated in a municipality, county, state, or federal prison
• No serious medical condition or psychiatric illness that would preclude signing the informed consent
• No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data
• Able to adhere to the study visit schedule and other study requirements

PRIOR CONCURRENT THERAPY:

• No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 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

Responsibility Role: SPONSOR

Principal Investigators

Ruben A. Mesa, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

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MC0788

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-01330

Identifier Type: REGISTRY

Identifier Source: secondary_id

07-005296

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000588839

Identifier Type: -

Identifier Source: org_study_id