Overview

Vandetanib to Treat Advanced Kidney Cancer

Status:
Terminated
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Cancer Institute (NCI)