Status:
TERMINATED
Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 phas...
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) myelof...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00630994
Start Date
March 1 2008
End Date
April 1 2012
Last Update
December 30 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905