IRB Number:

1507-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

- Find the highest dose of the cancer drugs called 17-AAG (17-Allylamino-17-
demethoxygeldanamycin) and cytarabine that can be given in a 60-day schedule to patients with advanced cancer without causing bad side effects
- Learn about the side effects of 17-AAG and cytarabine when given together
- Learn how the body handles or processes the drugs and learn the other effects the drugs have on the body using blood and bone marrow samples

17-AAG is an investigational drug that has not been approved by the U.S. Food and Drug
Administration (FDA), or any other regulatory agency, for commercial use but is approved by the FDA for use in this research study. Cytarabine has been approved by the FDA for the treatment of acute myelogenous leukemia. This study will provide information that will allow the investigators to further study if the combination is more effective than each drug given alone.

Who is Eligible to Participate in the Study?

- Age 18 or older
- Diagnosed with acute myelogenic leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic myelomonocytic leukemia (CMML), myelodysplastic syndromes (MDS)

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

What is Involved With this Study?

Before starting any study treatment, patients will have certain tests and procedures to determine if they are eligible to take part in this study. These include:
-Medical history/ physical exam
-Chest CT scan
-Pulmonary function tests
-Pulse oximetry
-Bone marrow biopsy
-Standard blood tests.
-For women able to become pregnant, a pregnancy test
-Echocardiogram or a MUGA scan

If patients are eligible and they agree to take part in this research study, they will receive two different drugs during their treatment. Treatment on this study will follow a 60-day schedule, and each 60-day period is known as a "cycle". This is a "phase 1" study. Phase 1 studies are available only to patients whose cancer cannot be helped by standard treatments. In phase 1 studies, a new drug or new combination of drugs is tested. The first patient(s) entering the study get a lower dose of the drug(s). If the lower dose is shown to be safe, the dose is slowly increased for new patients who enter the trial. 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.

Patients will be given cytarabine intravenously (through a needle into a vein) continuously beginning on Day 1 and ending on Day 5. They will also be given 17-AAG (17-Allylamino-17-demethoxygeldanamycin) on Day 3 for two hours (48 hours after the cytarabine was started) and on Day 6 for two hours (120 hours after the cytarabine was started). This 60-day schedule will be repeated as long as the patient does not have serious side effects and their cancer does not get worse.

During the treatment the patient will have their blood pressure, temperature and pulse checked throughout the infusions. Also, their potassium, calcium, and magnesium levels will be checked and an ECG (an electrocardiogram), which is a painless test involving an electrical measurement of the heart will be done each time the patient gets the 17-AAG infusion.

Patients will also have bone marrow biopsies and/or aspirates while they are participating in this study. The first bone marrow biopsy and/or aspirate will be done during the week before receiving treatment to see how the patient is doing. After beginning the study treatment, patients will have another bone marrow biopsy and/or aspirate on Day 3 and again on Day 4 as part of the research study during Cycle 1. Patients will have more bone marrow biopsies and/or aspirates when their doctor recommends that they have them to check their health.

If the patient and their research doctor decide that they will have more than one cycle of this treatment, patients will have their intravenous treatments of cytarabine and 17-AAG in the hospital, and they will not have any further blood tests or bone marrow tests for research purposes. However, if it is decided that they will have a second cycle of treatment, an echocardiogram will be done before the second cycle. If it is decided that the patient will not have more than one cycle of treatment, they will have an echocardiogram when this decision is made. Patients may be able to have up to 4 cycles of this treatment, if the patient and their research doctor decide that they should have that many cycles.

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 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, John Hopkins

Study Activation/Registration Date: 09/21/2007

IRB Review and Approval Date: 09/16/2004

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: Scott H. Kaufmann, MD, PhD

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

Last updated: 05/07/2008