Active Accrual: Protocols Recruiting New Patients

Protocol Number: 04-C-0238

Title: 17AAG to Treat Kidney Tumors in von Hippel-Lindau Disease
To inquire, contact Dr. Marston Linehan, +1.301.496.6353.

Summary: This study will examine whether the drug 17AAG (17-allylamino 17-demethoxygeldanamycin) can shrink kidney tumors in patients with Von Hippel-Lindau disease (VHL), a rare, inherited syndrome in which patients develop tumors in certain parts of the body. 17AAG contributes to the destruction of proteins in cells that may play a role in causing cancer and spurring tumor growth. The study will also look at the effect of 17AAG on other tumors patients may have that are caused by VHL, on the amount of blood vessels in the tumors, on the biologic activity of the tumor, and on cells circulating in the bloodstream, as well as the safety of the drug and its impact on the kidney tumor in patients whose tumor(s) is removed.

Patients 18 years of age and older with von Hippel-Lindau disease who have at least one kidney tumor large enough to pose a risk of metastasis (spread of the cancer to other parts of the body) may be eligible for this study. Candidates are screened with a medical history and physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI, see below), and blood and urine tests. Additional tests, including a 24-hour urine collection, ultrasound of the testicles in men, hearing test, eye exam, and MRI of the spine, may be done if recent test results are not available.

Participants undergo the following tests and procedures:

• MRI: This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. A catheter (plastic tube) is inserted into the patient’s arm to administer a contrast dye that enhances the images.

• Positron emission tomography (PET): Two types of PET scans may be done. One determines tumor activity by measuring the amount of sugar (glucose) the tumor absorbs, and the other measures tumor blood flow. For both studies, catheters are placed in a vein in each arm, one for giving a radioactive substance (a radiation-labeled sugar molecule for the tumor activity test and radiation-labeled water for the blood flow test), and the other for taking blood samples. The patient lies in the doughnut shaped scanner while images are obtained of various parts of the body where tumors are located.

• 17AAG treatment: Patients receive 17AAG infusions into a vein once a week for 3 weeks out of every 4, for 3 months. The infusions last up to 1 to 2 hours.

• Repeat testing: After 3 months, patients have repeat MRI and PET scans to measure changes in tumor activity, blood flow, and number of blood vessels in the tumor since the pre-treatment scans. They may have additional tests, including a CT scan, eye exam, and other tests to evaluate the effect of 17AAG on the tumors.

• Research blood draws: Blood samples are collected four times during the first week of treatment and then before each dose of 17AAG to determine the effects of the drug on blood counts, liver function, and other body functions, and to monitor safety.

Patients whose tumors shrink with 17AAG treatment may continue to receive the drug for another 12 weeks, followed by repeat MRI and PET scans. Those whose tumors do not shrunk or grow after 12 weeks on the study are asked to undergo surgery to remove the kidney tumors to reduce the chance of tumor spread.

Sponsoring Institute: National Cancer Institute (NCI)
To inquire, contact Dr. Marston Linehan, +1.301.496.6353.