IRB Number:

06-003532

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Background:
- PKCé is a protein that may help one type of lung cancer to grow.
- Gold sodium thiomalate (ATM) may block the effects of PKCé.
- This study is the first step in trying to find out if ATM can be used safely in the
treatment of the type of lung cancer that depends on PKCé for growth.
This study is being done:
- To find the highest dose of the PKCé inhibitor, ATM, that can be given to patients
with advanced non-small cell lung cancer (NSCLC) without causing bad side
effects;
- to learn if ATM can stop or slow the growth of a patient's NSCLC tumor;
- to learn about the side effects of ATM when given to patients with NSCLC; and
- to learn how the body handles or processes ATM and how ATM affects the body
using blood and tissue samples and in some cases, positron emission tomography
(PET) imaging.

Who is Eligible to Participate in the Study?

-Diagnosed with Advanced Non-Small Cell Lung Cancer
-Age 18 years or older
-No prior chemotherapy, immunotherapy, biologic therapy or radiation therapy for lung cancer within 3 weeks of enrolling on study

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Before patients start any study treatment, they will have certain tests and procedures to determine if they can take part in this study. The researcher will look at the patient's medical history, they will have a physical exam, and they will have standard blood tests and a urine
test done. If a patient is a woman who can become pregnant, they will also have a pregnancy test.
This study will test the idea that tumors that have certain changes of a gene called PKCé may be responsive to treatment with a type of agent called ATM, which has been used in the past for treatment of Rheumatoid Arthritis. Therefore, a piece of a patient's tumor from the
sample that was used to diagnose their NSCLC will be requested from their pathologist for testing. Patients can only be in this study if their tumor has these changes in the PKCé gene.
Once it is determined patients are eligible to be in this study, they will also be asked to have an additional 7 ml (less than one tablespoon) blood sample taken prior to starting the study agent. Similar samples will also be taken prior to therapy on week 3, 5, 7, 9 and
11. These samples will be used to help us study how ATM is processed in the body and how that might be related to how patients react to the therapy. These samples are taken for
research purposes only.
Treatment on this two-part study will follow a 4-week schedule, and each 4-week period is known as a "cycle". In the second part of the study, we are trying to find out more about the highest dose of the study drug that was safely given in the first part of the study. Patients will receive a smaller "test dose" of ATM one week before they begin their first cycle of therapy. This is done to make sure that they do not have any bad side effects from ATM. The dose of ATM that patients get will not increase during this study, but if they have bad side effects, their dose may be lowered at future visits.
Patients will also have up to 3 positron emission tomography (PET) imagings. A PET scan is a procedure in which a small amount of radioactive tracer is injected into a vein and then a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is used. These PET scans will be done at the start of the study, at week 5 of the study, and at week 12.
Patients will get ATM by an intramuscular injection (i.e. a shot in their muscle) once per week for a maximum of 12 weeks. Each week, the patient will have a blood test (approximately 1 tablespoon of blood) and urine test completed. These tests are needed to measure their
blood cell counts and blood chemistries.

How long will the Study run?

The length of time patients are in the study will depend on their weekly dose of ATM and how well their tumor responds to ATM. Patients will be treated with ATM each week for 12 weeks. If their tumor growth slows or stops altogether during those 12 weeks, they can continue to have the ATM treatment at the same dose level every 4 weeks (as long as it continues to be safe for the patient to do so).
As long as they do not have bad side effects, it is safe to have up to 1 gram of ATM in a lifetime. This means that if patients are in the group that receives the lowest dose of ATM and their tumor is responding to ATM, then they can choose to continue to receive ATM injections for 28 more doses (one every four weeks, which would be a little more than 2 years). If patients are in the group that receives the next higher dose of ATM, then they can continue to receive ATM injections for 8 more doses (one every four weeks which is about 8 months). If they are in the group that receives the highest dose of ATM, then patients
can have one more dose 4 weeks later. Three months after their last treatment on this study, follow-up information will be collected from the patient and then they will be off the study.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 01/25/2007

IRB Review and Approval Date: 11/03/2006

Study Type: Treatment

Projected Accrual: Up to 27 patients may be enrolled to participate at Mayo Clinic

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Julian Molina, M.D.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 07/03/2008