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


Phase 2
N/A
76 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Outcomes at 6 Weeks

Outcome 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.

Outcome Time Frame:

Baseline to 6 weeks timepoint (day 42)

Safety Issue:

No

Principal Investigator

Michael Andreeff, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

DM97-232

NCT ID:

NCT00483067

Start Date:

March 1998

Completion Date:

July 2008

Related Keywords:

  • Leukemia
  • Idiopathic Hypereosinophilic Syndrome
  • Leukemia
  • 2-Chlorodeoxyadenosine
  • Cladribine
  • Cytarabine
  • Ara-C
  • 2-CdA
  • G-CSF
  • HES
  • Leukemia
  • Hypereosinophilic Syndrome

Name

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