Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483067
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-06-05
Brief Title:
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome HES
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study 2-Chlorodeoxyadenosine 2-CdA and Cytarabine Ara-C in Idiopathic Hypereosinophilic Syndrome HES
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Before the study begins patients will have a physical exam blood tests and urine tests Women will have a pregnancy test A bone marrow sample will be taken This is done with a large needle Heart tests and an MRI scan of the brain will be done if there is a suspicion of disease in the heart or central nervous system
Patients in this study must have a catheter thin tube placed in a vein in the arm or under the collarbone This tube will be left in place throughout the study 2-CdA Cladribine will be given through the catheter 24 hours a day on days 2 to 6 Ara-C Cytarabine will be given through the catheter over 2 hours on days 1 3 4 5 and 6 Starting on day 9 patients will inject G-CSF under their skin once a day G-CSF helps blood counts return to normal Treatment will be given on an inpatient or outpatient basis The first course is normally done inpatient
During the study patients will have blood tests daily during the first week and every other day after that Bone marrow samples will be taken on days 14 21 and 28 Further bone marrow samples may be necessary to evaluate response Heart tests and MRI scans of the brain may be done
This is an investigational study G-CSF 2-CdA and Cytarabine are approved by the FDA for treatment of cancer Up to 40 patients will take part in this study Patients will be treated at M D Anderson or other centers A total of 40 people will take part in this study About 1 patient every 3 months will be enrolled at M D Anderson
Patients in this study must have a catheter thin tube placed in a vein in the arm or under the collarbone This tube will be left in place throughout the study 2-CdA Cladribine will be given through the catheter 24 hours a day on days 2 to 6 Ara-C Cytarabine will be given through the catheter over 2 hours on days 1 3 4 5 and 6 Starting on day 9 patients will inject G-CSF under their skin once a day G-CSF helps blood counts return to normal Treatment will be given on an inpatient or outpatient basis The first course is normally done inpatient
During the study patients will have blood tests daily during the first week and every other day after that Bone marrow samples will be taken on days 14 21 and 28 Further bone marrow samples may be necessary to evaluate response Heart tests and MRI scans of the brain may be done
This is an investigational study G-CSF 2-CdA and Cytarabine are approved by the FDA for treatment of cancer Up to 40 patients will take part in this study Patients will be treated at M D Anderson or other centers A total of 40 people will take part in this study About 1 patient every 3 months will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None