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

NCT00822887 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-06-26

No results posted yet for this study

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.

Conditions

  • Malignant Gliomas

Interventions

DRUG

Vandetanib

Dose level 1:100 mg qd Dose level 2:200 mg qd Dose level 3:300 mg qd

RADIATION

Fractionated Stereotactic Radiotherapy

All patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Changhu Chen, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-05-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00822887 on ClinicalTrials.gov