Inhaled Interleukin-2 in Treating Patients With Metastatic or Unresectable Cancer

May 20, 2014 updated by: University of Southern California

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 study.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Raymond A. Kempf, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1996

Primary Completion (Actual)

August 1, 2000

Study Completion (Actual)

August 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 15, 2004

First Posted (Estimate)

June 16, 2004

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065584 (0I-95-1)
  • LAC-USC-0I951
  • NCI-G97-1264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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