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Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer

Phase 2
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer

OBJECTIVES: I. Determine the response rate and median duration of response of interleukin-2
(IL-2) in patients with previously treated non-small cell lung cancer. II. Determine the
median survival of patients treated with IL-2. III. Further delineate the toxicity of IL-2
in these patients.

OUTLINE: This is an open label study. Patients receive bolus interleukin-2 on days 1-5 and
8-12. The cycle repeats every 3 weeks. Patient response is evaluated after 2 cycles.
Patients with stable disease, partial, or complete response may be treated with maintenance
IL-2 for up to 4 additional cycles. Patient evaluation is performed after every 2 cycles. At
this point, patients with stable or responding disease may be treated with IL-2 every 6
weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-small cell lung
cancer At least one prior systemic therapy OR prior radiation therapy Must have measurable
disease Previously irradiated sites of disease are not considered evaluable unless there
is radiologic documentation of progression

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy:
At least 3 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin greater than 10 g/dL
Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal:
Creatinine less than 2.0 mg/dL Cardiovascular: No prior history of myocardial infarction
within previous 6 months No uncompensated congestive heart failure No primary (not due to
electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions
Pulmonary: No dyspnea at rest or need for supplemental oxygen Patients with symptomatic
lung disease or extensive lung metastases must have oxygen saturation greater than 90%
Other: Not pregnant or nursing Negative pregnancy test Patients with elevated temperatures
greater than 100.5 F must have no occult infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent cyclosporin Chemotherapy: At
least 3 weeks since chemotherapy and recovered No concurrent methotrexate See Disease
Characteristics Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At
least 3 weeks since radiotherapy See Disease Characteristics Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Datchen F. Tai, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group


United States: Federal Government

Study ID:




Start Date:

January 1996

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Bloomington Hospital Bloomington, Indiana  47402
Bergan Mercy Medical Center Omaha, Nebraska  68124
St. Joseph Regional Cancer Center Bryan, Texas  77802