Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Confirmed pathologic diagnosis of myelodysplastic syndromes
- International Prognostic Scoring System score of intermediate-2 or high-risk
- Failed or progressed after 1 prior FDA-approved treatment for MDS OR refused the FDA-approved treatment
- Not a candidate for intensive or standard chemotherapy or stem cell transplantation, as determined by the treating physician
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 3 times ULN
- Creatinine < 2.0 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No comorbidity or condition that, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol or that would decrease life expectancy to < 3 months
- No active, serious infection not controlled by oral or IV antibiotics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Experimental
Treatment
G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive days of the treatment course 2-4 hours following the end of the clofarabine infusion. (SOC) Clofarabine starting at dose level 0. Dose-10 mg/m2 IV over 1 hour daily starting on day 1 for the first 5 consecutive days of the treatment course The G-CSF and cytarabine doses are fixed. The dose of clofarabine is initially fixed. For the subsequent cohort, the dose of clofarabine will be advanced to the next dose level.