Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if clofarabine given by mouth on a weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also be studied.
Disease Group: Leukemia
Treatment Agent: Clofarabine
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: 5 days
Return Visit: Every 4 to 8 weeks, up to a total of 12 courses of therapy about 2 to 3 years.
Home Care: Self medicated
Primary: Evaluate the response rate of oral clofarabine in MDS. Secondary: Evaluate survival and side effects.
IRB Review and Approval Date: OCT 19,2005
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Patients with MDS and >/= 5% blasts or IPSS risk intermediate or
high; patients with CMML.
2) No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2).
3) Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
4) Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
5) Hydroxyurea is permitted for control of counts prior to treatment.
6) Procrit, GCSF are allowed before therapy.
7) Performance 0-2 (ECOG). Adequate organ function including the following:Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 X ULN. Adequate cardiac functions (NYHA cardiac III-IV excluded).
8) Signed informed consent.
1) Nursing and pregnant females. Patients of childbearing potential
should practice effective methods of contraception. Child bearing
potential defined as not post-menopausal for 12 months or no previous
surgical sterilization. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her
treating physician immediately.
2) Active and uncontrolled infections.
3) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
4) Prior clofarabine treatment.