Overview

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes

Status:
Terminated
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or in peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and G-CSF in treating patients with myelodysplastic syndromes.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Nebraska
Collaborator:
National Cancer Institute (NCI)
Treatments:
Clofarabine
Cytarabine
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