Phase II Study of Vandetanib in Individuals With Kidney Cancer

Summary

This study will examine the effectiveness of an investigational drug called ZD6474 (also known as vandetanib or ZACTIMA). Vandetanib is an experimental drug that is designed to prevent the growth and development of new blood vessels on tumors and to prevent the direct growth of cancer cells. It has been tested in a number of clinical trials on adults with cancer, but the United States (U.S.) Food and Drug Administration has not specifically approved it as a cancer treatment. The purpose of this investigational study is to better understand how vandetanib affects humans who have kidney cancer related to von Hippel-Lindau (VHL) disease, and to develop tests that may improve researchers understanding of kidney cancer and its effects. Volunteers must be at least 18 years old and must have been diagnosed with kidney cancer related to VHL. Candidates must have a life expectancy greater than three months and must have at least one measurable renal tumor for study purposes. Candidates may not be receiving any other investigational agents or have been treated with an investigational drug within the past four weeks. Candidates who have had surgery, chemotherapy, or radiotherapy within the past four weeks will be excluded from the study. Candidates will be screened with a physical examination and medical history. During the study, participants will receive an oral dose of vandetanib once a day for 28 days (a treatment period known as a cycle). Participants will need to return to the National Institutes of Health every two weeks on the same day of the week as the first dose of vandetanib for a series of tests and procedures, including blood and urine tests and an electrocardiogram. Every 12 weeks, computerized tomography (CT) or magnetic resonance imaging (MRI) scans will be done to assess the size of participants tumors. Participants whose tumors do not grow and who do not have unacceptable side effects may continue to receive vandetanib to maintain the current condition, until researchers conclude the study....

Timeline

Start

2008-02-07

Primary completion

2014-06-20

Completion

2015-03

Publications

• Background Linehan WM, Lerman MI, Zbar B. Identification of the von Hippel-Lindau (VHL) gene. Its role in renal cancer. JAMA. 1995 Feb 15;273(7):564-70. No abstract available.
• Background Clifford SC, Maher ER. Von Hippel-Lindau disease: clinical and molecular perspectives. Adv Cancer Res. 2001;82:85-105. doi: 10.1016/s0065-230x(01)82003-0.
• Background Kaelin WG Jr. Molecular basis of the VHL hereditary cancer syndrome. Nat Rev Cancer. 2002 Sep;2(9):673-82. doi: 10.1038/nrc885.
• Background Brooks S, Linehan WM, Srinivasan R, Kong HH. Successful laser treatment of vandetanib-associated cutaneous pigmentation. Arch Dermatol. 2011 Mar;147(3):364-5. doi: 10.1001/archdermatol.2011.30. No abstract available.
• Background Vitael, S, Cunningham, D. Meleth, A., Bishop R., Clayton, Datile, M, Linehan WM, Srinivasan R, Meyerle, C. Development of a New Grading System for Corneal Verticillata. ARVO meeting May 8, 2013
• Background Vitael, S, Cunningham, D. Meleth, A., Bishop R., Clayton, Datile, M, Linehan WM, Srinivasan R, Meyerle, C. Development of a New Grading System for Corneal Verticillata. ARVO meeting May 2012.

Drugs

Indications