Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.