Overview

Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency

Status:
Completed
Trial end date:
2000-03-01
Target enrollment:
0
Participant gender:
All
Summary
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Treatments:
Interleukin-2
Criteria
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented common variable immunodeficiency defined as a reduction of serum IgG by at least
2 standard deviations

In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than
unstimulated cultures

--Prior/Concurrent Therapy--

No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone
(maximum 10 mg/day)

Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is
required

--Patient Characteristics--

Life expectancy: At least 24 months

Other: Not pregnant or nursing HIV negative