NCT00003009

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 1996

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

May 20, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

MeSH Terms

Interventions

aldesleukin

Study Officials

  • Raymond A. Kempf, MD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

February 1, 1996

Primary Completion

August 1, 2000

Study Completion

August 1, 2000

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)