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Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases


Phase 1/Phase 2
12 Years
N/A
Open (Enrolling)
Both
Sarcoma, Solid Tumors, Pulmonary Metastases, Lung Metastases, Osteosarcomas, Ewing Sarcoma

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Trial Information

Phase I/II Study of Aerosol Interleukin-2 for Pulmonary Metastases


Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of IL-2 based on when you join this study. Up to 8 dose levels of IL-2 will be
tested. Up to 3 participants will be enrolled at each dose level. The first group of
participants will receive the lowest dose level. Each new group will receive a higher dose
than the group before it, if no intolerable side effects were seen. This will continue
until the highest tolerable dose of IL-2 is found.

Study Drug Administration:

You will take IL-2 daily on Days 1-21 of each 28-day cycle. You will not take IL-2 on Days
22-28.

You will be taught in the clinic how to prepare the drug at home.

To take IL-2, you will breathe the drug mist through the mouthpiece of the nebulizer
machine, which will be provided. You will be told how to use the machine. You should bring
the machine with you to the study visits.

Each day you take IL-2, you will write down the date and the day of the study cycle. You
will also measure and record your heart rate and the level of oxygen in your blood. You
will be provided with a pulse oximeter to measure your oxygen level.

Each day while you are on study, you will use a small hand-held device to test your lung
function and answer questions about side effects you may be having. You will measure your
lung function by blowing hard for 5-7 seconds into the device. The device will also prompt
you to answer questions about side effects you may be having. The device will send this
information to MD Anderson using your internet connection. This will be described to you in
more detail, and you will be shown how to use the device.

Study Visits:

At all study visits, you will be asked about any drugs that you may be taking or any side
effects that you may be having.

On Day 1, 8, 15, and 22 of Cycle 1:

- Your medical history will be recorded.

- Blood (about ½ teaspoon) will be drawn for routine tests.

On Day 1 of Cycle 2:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 4 teaspoons) will be drawn for routine tests.

On Day 8 and 15 of Cycle 2 and beyond:

- Your medical history will be recorded.

- Blood (about ½ teaspoon) will be drawn for routine tests.

On Day 22 of Cycle 2 and beyond:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 4 teaspoons) will be drawn for routine tests. This routine blood draw may
include a pregnancy test if you are able to become pregnant. You may have a urine test
if you are able to become pregnant.

- You will have a lung function test.

- The amount of oxygen in your blood will be measured by a pulse oximeter.

- You will have a CT scan and x-ray of your chest.

Your local doctor may draw the blood and you may be contacted by phone about side effects
and medical history. The study team will explain to you how this will be arranged, if
possible.

You will have to return to the clinic before the start of each new cycle, to receive your
study drug supply for the next cycle.

End of Treatment Visit:

Within 14 days after your last dose of study drug:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 4 teaspoons) will be drawn for routine tests.This routine blood draw may
include a pregnancy test if you are able to become pregnant. You may have a urine test
if you are able to become pregnant.

- You will have a lung function test.

- The amount of oxygen in your blood will be measured by a pulse oximeter.

- You will have a CT scan and x-ray of your chest.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. IL-2 is FDA approved and commercially available when
given by vein to patients with melanoma and renal cell carcinoma. Its use in patients with
lung metastases and when given as an aerosol mist into the lungs is investigational.

IL-2, the portable nebulizer apparatus and air compressor to make the mist treatment, the
pulse oximeter device to measure your heart rate and oxygen saturation, and the lung
function device will be provided free of charge while you are on study. You will return the
machines at the end of the study.

Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients with diagnosis of lung metastases. Patients with no prior therapy are
eligible if there is no known superior alternative medical therapy. For phase II
expansion cohort diagnosis of sarcoma (Osteosarcomas and Ewing sarcoma family of
tumors) 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 bilirubin and AST, /=50% predicted, O2 sat at rest >/=90%
(off supplementary oxygen)

4. Age 12 or older

5. Performance status: ECOG performance status /= 16 or Lansky play >/=
80% for ages
6. Patients must have recovered to other investigational therapy, hormonal, biological, targeted agents. No radiotherapy
within 2 weeks: Exception: patients may have received palliative low dose
radiotherapy to the limbs (30 Gy or less) 1 week before this therapy -provided
pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy
field.

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

8. Patients with sarcoma, renal cell carcinoma, or melanoma with known resectable lung
metastases.

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 or patients with known
disease outside lungs and/or thorax.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response of Measurable Lesions to Aerosol IL-2

Outcome Description:

Response defined as complete response (CR) or partial response (PR) at the end of 2 months period, or stable disease (SD) that lasts for more than 4 months.

Outcome Time Frame:

2 months minimally, up to 4 months

Safety Issue:

No

Principal Investigator

Aung Naing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0700

NCT ID:

NCT01590069

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Sarcoma
  • Solid Tumors
  • Pulmonary Metastases
  • Lung Metastases
  • Osteosarcomas
  • Ewing Sarcoma
  • Sarcoma
  • Solid Tumors
  • Pulmonary Metastases
  • Lung metastases
  • Osteosarcomas
  • Ewing sarcoma
  • IL-2
  • Interleukin-2
  • Aldesleukin
  • Proleukin
  • Aerosol IL-2
  • Spirometry
  • Nebulizer
  • Pulse oximeter
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Osteosarcoma
  • Lung Neoplasms
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030