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
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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