Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Summary

This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and radiation therapy may kill more tumor cells.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

DRUG

Cediranib Maleate

Given PO

PROCEDURE

Diffusion Tensor Imaging

Undergo DTI

PROCEDURE

Diffusion Weighted Imaging

Undergo T1 weighted DCE-MRI

PROCEDURE

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI

RADIATION

Fludeoxyglucose F-18

Undergo 18 FDG PET

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Perfusion Magnetic Resonance Imaging

Undergo PWI

PROCEDURE

Positron Emission Tomography

Undergo 18 F FDG-PET

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Elizabeth R Gerstner, MD · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• United States

Study Locations