2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00483067

Purpose

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.

Condition	Intervention	Phase
Leukemia	Drug: 2-CdA Drug: Ara-C Drug: G-CSF	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine Cytarabine hydrochloride Granulocyte colony-stimulating factor Cladribine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To look at whether 2-chlorodeoxyadenosine (2-CdA) plus cytarabine helps patients with idiopathic hypereosinophilic syndrome. [ Time Frame: 11 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 1998
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2-CdA + Ara-C + G-CSF	Drug: 2-CdA 12 mg/m^2/day IV Continuous Infusion x 5 Days Drug: Ara-C 1 gm/m^2/day IV Over 2 Hours x 5 Days Drug: G-CSF 5 mcg/kg/day SQ Starting Day 9

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.

Eligibility

Ages Eligible for Study:	up to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (see Appendix B).
Life expectancy is not severely limited by concomitant illness.
Serum creatinine < 2 mg/dL.
Serum bilirubin < 2 x upper limit of normal (2 mg/dL).
SGPT < 2 x 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483067

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Michael Andreeff, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Michael Andreeff, MD, PhD/Professor )
Study ID Numbers:	DM97-232
Study First Received:	June 5, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00483067
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Idiopathic Hypereosinophilic Syndrome
Leukemia
2-Chlorodeoxyadenosine
Cladribine
Cytarabine

Ara-C
2-CdA
G-CSF
HES

Study placed in the following topic categories:

Cladribine
Idiopathic hypereosinophilic syndrome
Leukemia
Hematologic Diseases
Hypereosinophilic Syndrome

Leukocyte Disorders
Hypereosinophilic syndrome
Eosinophilia
Cytarabine
2-chloro-3'-deoxyadenosine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Disease
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009