Phase II Study of Vandetanib in Individuals With Kidney Cancer
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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....