IRB Number:

05-004048

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to:
- test the safety of a drug called Aminoflavone (AFP464) and see what effects (good and bad) it has on patients with solid tumors;
- find the highest dose of AFP464 that can be given without causing bad side
effects; and to
- learn how the body handles or processes the drug.

Who is Eligible to Participate in the Study?

Patients with metastatic solid tumors who are refractory (resistant) to available therapy or for whom standard systemic therapy does not exist.

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

What is Involved With this Study?

- Medical exams
- Blood samples
- Collection (Swab) of cells from inner lining of mouth
- CT or MRI and chest x-ray
- Pulmonary tests (PFTs)
- Urine samples
- Over night stay at the Clinical Research Unit at Saint Marys Hospital, Rochester, MN

How long will the Study run?

Patients will be in the study until the side effects are too bad or the patient decides to stop or if the cancer gets worse. Patients will be followed for up to 3 months after the last infusion with AFP464 so that the researchers can watch the patient's health status.

Sponsor(s): Mayo Clinic, National Cancer Institute (NCI)

Study Activation/Registration Date: 1/24/2007

IRB Review and Approval Date: 2/03/2006

Study Type: Treatment

Projected Accrual: 70 patients

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

Principal Investigator: Matthew Goetz, 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

Last updated: 05/23/2008