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

August 1, 2012 updated by: M.D. Anderson Cancer Center

Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)

Primary Objectives:

  1. To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
  2. To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
  3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 76 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Age less than 76 years old.
  3. Patient is not pregnant.
  4. Zubrod performance status < 3.
  5. Life expectancy is not severely limited by concomitant illness.
  6. Serum creatinine < 2 mg/dL.
  7. Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
  8. Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
  9. 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:

  1. Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
  2. Presence of an active infection.
  3. HIV positive.
  4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
  5. Recent history of parasite infection.
  6. Recent history of allergic reaction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: 2-CdA
12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
Other Names:
  • 2-Chlorodeoxyadenosine
  • Cladribine
Drug: Ara-C
1 gm/m^2/day IV Over 2 Hours x 5 Days
Other Names:
  • Cytarabine
Drug: G-CSF (Granulocyte colony-stimulating factor)
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Other Names:
  • Filgrastim
  • Neupogen
  • Granulocyte colony-stimulating factor
  • GCSF

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

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Michael Andreeff, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

June 5, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (ESTIMATE)

June 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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