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A Phase I Study of Inhalation of Interleukin-2 (IL-2) in Patients With Metastatic or Unresectable Cancer

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Raymond A. Kempf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000065584 (0I-95-1)



Start Date:

February 1996

Completion Date:

August 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800