2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2-CdA
Ara-C
G-CSF (Granulocyte colony-stimulating factor)
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Idiopathic Hypereosinophilic Syndrome, Leukemia, 2-Chlorodeoxyadenosine, Cladribine, Cytarabine, Ara-C, 2-CdA, G-CSF, HES
Eligibility Criteria
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.
Sites / Locations
- U.T.M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2-CdA + Ara-C + G-CSF
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00483067
First Posted
June 5, 2007
Last Updated
August 1, 2012
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00483067
Brief Title
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Official Title
Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Idiopathic Hypereosinophilic Syndrome, Leukemia, 2-Chlorodeoxyadenosine, Cladribine, Cytarabine, Ara-C, 2-CdA, G-CSF, HES
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-CdA + Ara-C + G-CSF
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
2-CdA
Other Intervention Name(s)
2-Chlorodeoxyadenosine, Cladribine
Intervention Description
12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
Intervention Type
Drug
Intervention Name(s)
Ara-C
Other Intervention Name(s)
Cytarabine
Intervention Description
1 gm/m^2/day IV Over 2 Hours x 5 Days
Intervention Type
Drug
Intervention Name(s)
G-CSF (Granulocyte colony-stimulating factor)
Other Intervention Name(s)
Filgrastim, Neupogen, Granulocyte colony-stimulating factor, GCSF
Intervention Description
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Primary Outcome Measure Information:
Title
Patient Outcomes at 6 Weeks
Description
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.
Time Frame
Baseline to 6 weeks timepoint (day 42)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Andreeff, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.T.M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website
Learn more about this trial
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
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