2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

NCT00483067 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-08-02

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
2. To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.

Conditions

Interventions

DRUG

2-CdA

12 mg/m\^2/day by vein (IV) Continuous Infusion x 5 Days

DRUG

Ara-C

1 gm/m\^2/day IV Over 2 Hours x 5 Days

DRUG

G-CSF (Granulocyte colony-stimulating factor)

5 mcg/kg/day given under the skin (subcutaneously) starting Day 9

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael Andreeff, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2006-03-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00483067 on ClinicalTrials.gov