Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Outcomes at 6 Weeks
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.
Baseline to 6 weeks timepoint (day 42)
Michael Andreeff, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|