RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
Giving interleukin-2 in different ways may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating
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
DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic cancer
Confirmed by biopsy or fine needle aspiration Tumors must predominantly involve the lung
Measurable or evaluable disease No lymphomas or leukemias No AIDS associate Kaposi's
Sarcoma No uncontrolled brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: At
least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count within normal limits
Hepatic: Bilirubin no greater than 2 times normal Renal: Creatinine no greater than 2.0
mg/dL Cardiovascular: Adequate cardiovascular system with NYHA Class 0 or I No
uncontrolled cardiac arrhythmias Pulmonary: FEV1 at least 65% of predicted FVC at least
65% of predicted No asthma or bronchial obstruction that would prevent the delivery of
IL-2 to all lobes of the lung Other: HIV negative No medical or psychological criteria
that would make patient unable to tolerate the treatment Not pregnant or nursing Adequate
contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 Prior biologic response
therapy allowed No chronic use of immunosuppressive medicines Chemotherapy: Prior
chemotherapy allowed Endocrine therapy: No chronic steroid use Prior hormonal therapy
allowed Radiotherapy: No prior or concurrent radiotherapy except as palliative to areas of
painful metastases outside the lung Surgery: Not specified