MDACC Study Summary DM97-232 (Archived)

Study Summary
No. DM97-232:.......Leukemia; Other Supportive......Michael Andreeff......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	DM97-232

Study Title:	Phase II Study: 2-Chlorodeoxyadenosine and Cytarabine in Idiopathic Hypereosinophilic Syndrome

Physician

New Patient Referral



Name:	Michael Andreeff	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7260 Contact us about clinical trials

General Information



Disease Group:	Leukemia Other Supportive	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	All bone marrow procedures must be performed at MDACC. Participants must be at MDACC for the IV drug administration (Days 1-7) and bone marrow aspirates on Days 14, 21, and 28. Research blood is scheduled on Day 28.

Treatment Agents:	Cladribine Cytarabine G-CSF	Home Care:	Follow-up care (blood work every other day untill WBC >= 500/mm^3, chemistry studies twice a week until response, clinic visits and lab reviews) may be carried out with a home physician.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Drug administration will occur over a span of 7 days. Patients will be discharged after IV drug completion and be followed in the clinic. If induction treatment is well tolerated, subsequent treatments may be given as outpatient therapy.


Description/ Intervention:	Treatment: This clinical research study will look at whether 2-chlorodeoxyadenosine (2-CdA) plus cytarabine helps patients with idiopathic hypereosinophilic syndrome. In this syndrome, the number of white blood cells (eosinophils) is greatly increased, and these cells invade the heart, brain, liver, and lungs.

Study Objectives / Outcomes

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 Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	03/03/2003

Study Type:

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 (see Appendix B).

5) Life expectancy is not severely limited by concomitant illness.

6) Serum creatinine < 2 mg/dL.

7) Serum bilirubin < 2 x upper limit of normal (2 mg/dL).

8) SGPT < 2 x 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.

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