Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas (IRUSZACT0073)
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.
Radiation: Fractionated Stereotactic Radiotherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of Vandetanib (ZACTIMA, ZD6474) With Hypofractionated Stereotactic Radiotherapy in Patients With Recurrent Malignant Gliomas|
- Incidence of acute and delayed ≥ grade 3 Central nervous system (CNS) toxicity by Common Terminology Criteria (CTC) v.3. [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
- Incidence of acute and delayed ≥ grade 3 non-CNS toxicity [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
- Progression-free survival at 6 months [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
- Objective response rate [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
- Quality of survival [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Dose level 1:100 mg qd, 2:200 mg qd, 3:300 mg qd. Fractionated Stereotactic Radiotherapy: all patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.
Dose level 1:100 mg qd Dose level 2:200 mg qd Dose level 3:300 mg qd
Other Name: ZD6474, ZactimaRadiation: Fractionated Stereotactic Radiotherapy
All patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00822887
|United States, Colorado|
|University of Colorado Health Science Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Changhu Chen, MD||University of Colorado, Denver|