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

NCT00503880 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-09-18

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

filgrastim

subcutaneously one day prior to treatment

DRUG

clofarabine

single IV dose over 1 hour daily for 5 days

DRUG

cytarabine

subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion

GENETIC

microarray analysis

Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.

PROCEDURE

biopsy

bone marrow biopsy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Lori J Maness, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-07
Primary Completion
2009-10-13
Completion
2009-10-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503880 on ClinicalTrials.gov