Status:
COMPLETED
Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells. If you are found to be eligible, you will be randomly assigned (as in the roll of...
Eligibility Criteria
Inclusion
- Patients with MDS and \>/= 5% blasts or IPSS risk intermediate or high; patients with Chronic myelomonocytic leukemia (CMML).
- No prior intensive chemotherapy or high-dose ara-C (\>/= 1g/m2).
- Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
- 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.
- Hydroxyurea is permitted for control of counts prior to treatment.
- Procrit, GCSF are allowed before therapy.
- 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).
- Signed informed consent.
Exclusion
- 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.
- Active and uncontrolled infections.
- 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.
- Prior clofarabine treatment.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00299156
Start Date
March 1 2006
End Date
December 1 2012
Last Update
November 3 2015
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030