Vandetanib to Treat Advanced Kidney Cancer

Summary

Background: * One way tumors are able to grow is by forming new blood vessels that supply it with nutrients and oxygen. * Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. * Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow. Objectives: * To determine whether vandetanib can cause tumors to shrink or stabilize in patients with advanced kidney cancer. * To determine how vandetanib may work in people with kidney cancer and to develop tests that may be helpful in studying kidney cancer. Eligibility: -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has worsened after treatment with one or more of the following drugs: sunitinib, sorafenib, interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs due to unacceptable side effects; or patients who are unable to receive standard treatment. Design: * Patients take a vandetanib pill once a day in 28-day cycles. * Patients are followed in the clinic every 2 weeks during the first month of treatment and then every 4 weeks for a physical examination, blood and urine tests, electrocardiogram and a review of any drug side effects. * Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and again about 4 and 8 weeks after starting treatment * Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done before starting vandetanib treatment and after 4 weeks of treatment to look for drug effects on the tumor.

Timeline

Start

2007-12

Primary completion

2010-06

Completion

2010-06

Publications

• Background Zambrano NR, Lubensky IA, Merino MJ, Linehan WM, Walther MM. Histopathology and molecular genetics of renal tumors toward unification of a classification system. J Urol. 1999 Oct;162(4):1246-58.
• Background Chow WH, Devesa SS, Warren JL, Fraumeni JF Jr. Rising incidence of renal cell cancer in the United States. JAMA. 1999 May 5;281(17):1628-31. doi: 10.1001/jama.281.17.1628.
• Background Phillips JL, Pavlovich CP, Walther M, Ried T, Linehan WM. The genetic basis of renal epithelial tumors: advances in research and its impact on prognosis and therapy. Curr Opin Urol. 2001 Sep;11(5):463-9. doi: 10.1097/00042307-200109000-00003.

Drugs

Indications