2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
NCT ID: NCT00483067
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
1998-03-31
2008-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2-CdA + Ara-C + G-CSF
2-CdA 12 mg/m\^2/day by vein (IV) Continuous Infusion and Ara-C 1 gm/m\^2/day IV for 5 Days with G-CSF 5 mcg/kg/day subcutaneously starting Day 9
2-CdA
12 mg/m\^2/day by vein (IV) Continuous Infusion x 5 Days
Ara-C
1 gm/m\^2/day IV Over 2 Hours x 5 Days
G-CSF (Granulocyte colony-stimulating factor)
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Interventions
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2-CdA
12 mg/m\^2/day by vein (IV) Continuous Infusion x 5 Days
Ara-C
1 gm/m\^2/day IV Over 2 Hours x 5 Days
G-CSF (Granulocyte colony-stimulating factor)
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age less than 76 years old.
3. Patient is not pregnant.
4. Zubrod performance status \< 3.
5. Life expectancy is not severely limited by concomitant illness.
6. Serum creatinine \< 2 mg/dL.
7. Serum bilirubin \< 2 times upper limit of normal (2 mg/dL).
8. Alanine aminotransferase (SGPT) \< 2 times upper limit of normal (112 IU/L).
9. Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.
Exclusion Criteria
2. Presence of an active infection.
3. HIV positive.
4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
5. Recent history of parasite infection.
6. Recent history of allergic reaction.
76 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael Andreeff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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DM97-232
Identifier Type: -
Identifier Source: org_study_id