A Phase I Study of Inhalation of Interleukin-2 (IL-2) in Patients With Metastatic or Unresectable Cancer
OBJECTIVES: I. Define the safe and tolerance of an inhaled interleukin-2 (IL-2) administered
once or twice a day. II. Determine blood levels of IL-2 and whether there is detectable
stimulation of immune cells in patients receiving inhalation IL-2. III. Determine whether
there is any shrinkage of pulmonary lesions of patients treated on this study.
OUTLINE: This is a two arm, escalating dose study of interleukin-2 (IL-2). In Arm I patients
in cohorts of 3-6 are administered daily inhalations of IL-2 over 15 minutes on Monday
through Friday for 4 consecutive weeks. At least 3 patients are treated at each dose level,
and all patients in a cohort are observed for at least 2 weeks before escalating to a higher
dose in absence of dose limiting toxicity. Escalation stops when maximum tolerated dose
(MTD) is determined. In Arm II the initial dose is 25 percent of the MTD determined in Arm I
administered by inhalation twice daily on Monday through Friday for 4 weeks. Subsequent
patient cohorts receive doses escalated by 33 percent above the previous dose level.
Responding patients continue treatment cycles of 4 weeks with 2 weeks of rest until they
develop progressive disease or intolerable toxicity. Stable patients may stay on treatment
for a maximum of 4 cycles.
PROJECTED ACCRUAL: A minimum of 12-15 and a maximum of 30 patients will be accrued for this
Primary Purpose: Treatment
Raymond A. Kempf, MD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|