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| Tracking Information | |||||
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| First Received Date ICMJE | June 5, 2007 | ||||
| Last Updated Date | June 6, 2008 | ||||
| Start Date ICMJE | March 1998 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To look at whether 2-chlorodeoxyadenosine (2-CdA) plus cytarabine helps patients with idiopathic hypereosinophilic syndrome. [ Time Frame: 11 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00483067 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
Determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils. [ Time Frame: 10 Years ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) | ||||
| Official Title ICMJE | Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES) | ||||
| Brief Summary | Primary Objectives:
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: 2-CdA + Ara-C + G-CSF | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 76 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00483067 | ||||
| Responsible Party | Michael Andreeff, MD, PhD/Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | DM97-232 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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