- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00483067
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
Primary Objectives:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- U.T.M.D. Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (> 6 months) hypereosinophilia (1,500/mm^3); and (3) signs or symptoms of organ involvement.
- Age less than 76 years old.
- Patient is not pregnant.
- Zubrod performance status < 3.
- Life expectancy is not severely limited by concomitant illness.
- Serum creatinine < 2 mg/dL.
- Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
- Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
- 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:
- Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
- Presence of an active infection.
- HIV positive.
- Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
- Recent history of parasite infection.
- Recent history of allergic reaction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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:
1 gm/m^2/day IV Over 2 Hours x 5 Days
Other Names:
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 6 weeks timepoint (day 42)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Andreeff, MD, PhD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hematologic Diseases
- Leukocyte Disorders
- Eosinophilia
- Hypereosinophilic Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Lenograstim
- Cytarabine
- Cladribine
Other Study ID Numbers
- DM97-232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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