IRB Number:

1508-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to:
- Find the highest dose of the cancer drugs called 17AAG and PS341 that can be given to patients with advanced cancers without causing unacceptable side effects
- Learn about the side effects of 17AAG and PS341 when given together
-
The combination of 17AAG and PS341 is investigational. This means that the combination has not been approved by the U.S. Food and Drug Administration (FDA). This is a "phase I" study. Phase I studies are offered only to patients for whom standard treatments have not been helpful.
To find the highest safe doses of 17AAG and PS341 that can be given together, the first group of three to six patients will receive lower doses of the drugs. If these patients do not have severe side effects, the next group of three to six patients will get higher doses of one of the two drugs. The doses will be increased until at least some patients have severe side effects.

The dose that a patient gets may increase during this study, but if they have bad side effects their dose may also be lowered at future visits. All patients will be watched carefully for any serious side effects. These side effects cannot be completely known ahead of time. Phase I studies may involve significant risks for this reason.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with cancer without potentially curative therapeutic (treatment) options

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

What is Involved With this Study?

If patients agree to take part in this study, they may need the following tests/ procedures:

- Physical exam/ medical history
- Height and weight will be measured
- Blood pressure, temperature, and pulse will be checked
- Pregnancy test will be done if patient is a woman able to become pregnant
- Blood tests
- Measurement of patient's tumor using x-ray or other special cameras (CT, MRI) that take pictures of the tumors
- EKGs (electrocardiograms), which are a painless test involving an electrical measurement of the heart.
- Multigated acquisition (usually just called a "MUGA") which is another type of test to evaluate the heart
- Lung function tests done, including pulse oximetry and pulmonary function tests

In this study, a "cycle" is three weeks long (21 days), during which the patient will get treatment only during the first two weeks of each cycle. For the first cycle only during this study patients will only be given 17-AAG into a vein in their arm over one to two hours on Day 1. On Days 4, 8, and 11 they will be given 17-AAG over 60 minutes followed by PS-341 into a vein over several seconds. Patients will then have a 1-week rest period when no treatment will be given.

For all other cycles patients will be given 17-AAG into a vein in their arm over one to two hours, then PS-341 into a vein over several seconds, once on Days 1, 4, 8, and 11 of each cycle. This schedule (two weeks with treatment, one week without treatment) will be repeated as long as the patient has no serious side effects and the cancer is not getting worse.

Patients will have blood tests weekly during this study. These tests are needed to measure their blood cell counts and/or blood chemistries. In addition, their potassium, calcium, and magnesium levels will be checked each time they get the 17AAG infusion, and they will have EKGs again during the first cycle, before, during, and after each treatment with 17AAG. In some patients, X-rays, CT scans, and/or magnetic resonance imaging (MRI) tests may also be done before starting treatment and following treatment to measure the cancer. These blood tests and measurement exams are part of the routine care given to cancer patients. Patients will need to return to Mayo Clinic for tests and examinations.

How long will the Study run?

Patients will be in the study until the side effects are too bad or they decide to stop or if their cancer gets worse. Three months after the patient's 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, Wayne State University

Study Activation/Registration Date: 03/07/2007

IRB Review and Approval Date: 08/05/2004

Study Type: Dosing/Treatment

Projected Accrual: The plan is to have up to 42 patients participate from multiple medical centers

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

Principal Investigator: Charles Erlichman, MD

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
• Scottsdale and Phoenix, AZ

Last updated: 12/19/2008