A Phase I Dose Escalation Study for Patients With Recurrent Malignant Gliomas
Recruitment status was Recruiting
This is a clinical trial (a type of research study). Clinical trials include only patients who choose to take part. You are being asked to take part in this study because you have a brain tumor that continued to grow despite prior therapy. Currently, there is no known effective treatment for your brain tumor. Please take your time to make your decision.
The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy. Vandetanib will be called "study drug" in the remainder of this consent form.
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 you will receive will depend on the stage the study has reached at the time you decide to participate.
In addition to taking the study drug you will also receive radiation therapy to your brain tumor for 3 days.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of Vandetanib (ZactimaTM , ZD6474) With Hypofractionated Stereotactic Radiotherapy in Patients With Recurrent Malignant Gliomas|
- Incidence of acute and delayed ≥ grade 3 CNS toxicity by CTC v.3. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
VANDETANIB Dose Escalation - Phase I
Dose level Dose
a Doses for VANDETANIB are stated as exact dose in mg. VANDETANIB starts 7 days before radiation and continues for 12 months, or until disease progression or dose-limiting toxicities.
b Radiation is given one fraction a day for three consecutive days.
Show Detailed Description
|Contact: Changu Chen, MD||720-8480234||Changhu.firstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Cancer Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Changhu Chen, MD 720-848-0234 Changu.Chen@uchsc.edu|
|Principal Investigator: Changhu Chen, MD|
|Principal Investigator:||Changhu Chen, MD||University of Colorado, Denver|