2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
|ClinicalTrials.gov Identifier: NCT00483067|
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : August 2, 2012
- To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
- To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
- To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: 2-CdA Drug: Ara-C Drug: G-CSF (Granulocyte colony-stimulating factor)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)|
|Study Start Date :||March 1998|
|Primary Completion Date :||March 2006|
|Study Completion Date :||July 2008|
Experimental: 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
12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
Other Names:Drug: Ara-C
1 gm/m^2/day IV Over 2 Hours x 5 Days
Other Name: CytarabineDrug: G-CSF (Granulocyte colony-stimulating factor)
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
- Patient Outcomes at 6 Weeks [ Time Frame: Baseline to 6 weeks timepoint (day 42) ]Patient outcomes defined at 6 weeks as Complete Remission (CR), absolute eosinophil count less than 1,500/mm3 and less than 5% of eosinophilic infiltrates in the bone marrow; and PR (partial response) defined as major clinical improvement without meeting the criteria specified for CR including an improvement in performance status to Zubrod's 0 or 1 along with clearance of clinical signs and symptoms of disease that are present at baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483067
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Andreeff, MD, PhD||M.D. Anderson Cancer Center|