Overview

Aerosol IL-2 for Pulmonary Metastases

Status:
Active, not recruiting
Trial end date:
0000-00-00
Target enrollment:
56
Participant gender:
Both
Summary
The goal of this clinical research study is find the highest tolerable dose of interleukin-2 (IL-2) that can be given as an inhaled mist to patients with lung metastases. The safety of this drug using this administration will also be studied. IL-2 is a protein that triggers white blood cells, called natural killer cells or T-cells, to kill cancer cells. When given as a shot or by vein, IL-2 has been known to cause fevers and flu-like side effects, including rashes, fatigue, and extra fluid in the skin or lungs. These symptoms are less when IL-2 is inhaled as a mist into your body.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Aldesleukin
Interleukin-2
Last Updated:
2016-12-05
Criteria
Inclusion Criteria:

1. Patients with diagnosis of advanced cancer with lung metastases. Patients with no
prior therapy are eligible if there is no known superior alternative medical therapy.
For phase Ib expansion cohort diagnosis of osteosarcoma with lung metastases will be
required.

2. Willing to comply with protocol therapy and required safety monitoring (self report,
pulse oximetry, remote spirometry, labs)

3. Adequate organ function as defined by : renal- creatinine normal (ULN), hepatic- bilirubin and AST, /=50% predicted,
O2 sat at rest >/=90% (off supplementary oxygen)

4. Age >/=12 and
5. Performance status: ECOG performance status /= 16 or Lansky play >/=
80% for ages
6. Patients must have recovered to loss) from any prior chemotherapy, other investigational therapy, hormonal,
biological, targeted agents.

7. No radiotherapy within 2 weeks: Exception: patients may receive palliative low dose
radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the
treating physician. Palliative radiotherapy could be given before aerosol treatment
is started if necessary.

8. Subjects have to be able to read and understand English.

9. Patients with advanced cancer with resectable lung metastases.

10. Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease
outside the lungs and/or thorax.

Exclusion Criteria:

1. Currently being treated with bronchodilators or corticosteroids.

2. Females: pregnant or breast feeding and if of child bearing potential (e.g. female of
childbearing age that has not been amenorrheic for at least 12 consecutive month or
surgically sterilized) not willing to use effective contraception

3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study
requirements.

4. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath
and/or wheezing and/or fatigue grade >/= 2 (CTCAE v4.0)

5. Patients with unresectable lung metastases.

6. Patients without sarcoma, renal cell carcinoma, or melanoma.