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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: 2-chloro-3'-deoxyadenosine; Cladribine; Cytarabine; Lenograstim; Sargramostim

Criteria

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.