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Name of the Trial

Phase II Study of Vandetanib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma (NCI-08-C-0039). See the protocol summary ³.

Principal Investigators

Dr. W. Marston Linehan and Dr. Ramaprasad Srinivasan (Lead Investigator), NCI Center for Cancer Research.

Dr. W. Marston Linehan Principal Investigator

Why This Trial Is Important

Renal cell carcinoma (RCC), the most common type of kidney cancer, often stimulates the growth of a large supply of new blood vessels (angiogenesis) to provide the oxygen and nutrients needed for continued tumor growth. Two drugs recently approved by the U.S. Food and Drug Administration for the treatment of patients with RCC, sorafenib ⁴ (Nexavar) and sunitinib ⁵ (Sutent), work by disrupting the angiogenesis process. However, RCC tumors often develop resistance to these drugs.

A new drug called vandetanib (Zactima) also inhibits angiogenesis by interfering with a protein involved in the process: vascular endothelial growth factor receptor 2 (VEGFR2). In addition, vandetanib also inhibits epidermal growth factor receptor (EGFR), a protein that mediates several functions essential for tumor cell growth. Clear cell RCC "is characterized by mutations in a gene we identified that is called the VHL gene," explained Dr. Linehan. "VHL regulates a number of things, including angiogenesis. Vandetanib targets two important parts of the VHL gene pathway-VEGFR2 and EGFR."

In this randomized trial, patients who have RCC that cannot be surgically removed (unresectable) or that has spread (metastatic) and who have previously received sorafenib or sunitinib will take vandetanib daily until their disease progresses or they develop unacceptable side effects.

In addition to monitoring the patients' tumors, the researchers will perform magnetic resonance imaging scans to visualize how vandetanib affects the blood supply to the tumors. The researchers will also collect blood samples from all participants to see if vandetanib is affecting the targeted proteins in the VHL gene pathway.

"We spent 10 years identifying this gene here at NCI, so we're thrilled to be conducting this trial targeting the VHL pathway," said Dr. Linehan.

For More Information

See the lists of entry criteria and trial contact information ³ or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

Glossary Terms

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

The functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA, and most genes contain the information for making a specific protein.

A procedure in which radio waves and a powerful magnet linked to a computer is used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Magnetic resonance imaging makes better images of organs and soft tissue than other scanning techniques, such as computed tomography (CT) or x-ray. Magnetic resonance imaging is especially useful for imaging the brain, the spine, the soft tissue of joints, and the inside of bones. Also called MRI, NMRI, and nuclear magnetic resonance imaging.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A substance being studied in the treatment of lung cancer and other types of cancer. It may block the growth and spread of tumor cells and prevent the growth of new blood vessels that tumors need to grow. Vandetanib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Also called Zactima.

A substance made by cells that stimulates new blood vessel formation. Also called VEGF.