2 Arm Study of Clofarabine IV in MDS Patients

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.

Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.

Secondary Objective: Compare response durations, survivals and side effects of the two schedules.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

1. Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (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 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded).

8. Signed informed consent.

Exclusion Criteria:

1. Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. 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.