MedTrace Logo

Vandetanib to Treat Advanced Kidney Cancer

NCT01372813 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-10-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Advanced Clear Cell Renal Carcinoma

Interventions

DRUG

vandetanib

Daily dose 300mg/day by mouth, 28 day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • W. Marston Linehan, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372813 on ClinicalTrials.gov