Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas

Summary

The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy. This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of cancers. This will be a dose escalation study. A dose escalation study means that successive groups of patients will receive higher doses of the study drug. There are three dose levels. The dose of the study drug received will depend on the stage the study has reached at the time a patient decides to participate. In addition to taking the study drug patients will also receive radiation therapy to the brain tumor for 3 days. Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days after radiation completed) dose limiting toxicities.

Timeline

Start

2007-03

Primary completion

2010-05

Completion

2011-01

Publications

• Fields EC, Damek D, Gaspar LE, Liu AK, Kavanagh BD, Waziri A, Lillehei K, Chen C. Phase I dose escalation trial of vandetanib with fractionated radiosurgery in patients with recurrent malignant gliomas. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):51-7. doi: 10.1016/j.ijrobp.2010.09.008. Epub 2010 Oct 29.

Drugs

Indications