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Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma

2014-08-27 03:16:09 | BioPortfolio

Summary

RATIONALE: 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. Cediranib maleate 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. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.

PURPOSE: This randomized phase II trial is studying temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma.

Description

OBJECTIVES:

Primary

- To determine if the addition of cediranib maleate to conventional chemoradiotherapy and adjuvant temozolomide enhances treatment efficacy, as measured by the 6-month progression-free survival (PFS) rate, in patients with newly diagnosed glioblastoma.

Secondary

- To determine if the addition of cediranib maleate to conventional chemoradiotherapy and adjuvant temozolomide enhances treatment efficacy, as measured by overall survival (OS) and PFS, in these patients.

- To determine if there is an association between tumor MGMT gene methylation status, treatment response, and outcome.

- To compare the toxicities of conventional chemoradiotherapy and adjuvant temozolomide with vs without cediranib maleate in these patients.

- To evaluate whether 6-month PFS is associated with OS of these patients.

Tertiary

- To assess the association between OS and change in each of the following markers: Ktrans, gradient echo CBV, and [18F]FLT Ki and K1 from T0 to T1 and from T1 to T3.

- To assess the association between PFS and change in each of the following markers: Ktrans, gradient echo CBV, and [18F]FLT Ki and K1 from T0 to T1 and from T1 to T3.

- To assess the association between OS and PFS and the T0 values of each of the following markers: Ktrans, gradient echo CBV, and [18F]FLT Ki and K1.

- To assess the relationship between [18F]FLT Ki and K1 and markers of tumor proliferation, both cross-sectionally and longitudinally.

- To evaluate the reproducibility of [18F]FLT Ki and K1 measurements.

- To assess the association between OS and PFS and the change in the "vascular normalization index" between T0 and T1.

OUTLINE: This is a multicenter study. Patients are stratified according to recursive partitioning analysis class (III vs IV vs V) and MGMT methylation status (methylated vs unmethylated vs invalid). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral cediranib maleate once daily for 3 days. Patients then undergo radiotherapy (intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy) once daily, 5 days a week, for 6 weeks and receive oral temozolomide once daily and oral cediranib maleate once daily for 6 weeks. Patients then receive oral cediranib maleate alone once daily for 28 days. Patients then receive oral temozolomide once daily for 5 days and oral cediranib maleate once daily for 28 days. Treatment with temozolomide and cediranib maleate repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral placebo once daily for 3 days. Patients then undergo radiotherapy (intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy) once daily, 5 days a week, for 6 weeks and receive oral temozolomide once daily and oral placebo once daily for 6 weeks. Patients then receive oral placebo alone once daily for 28 days. Patients then receive oral temozolomide once daily for 5 days and oral placebo once daily for 28 days. Treatment with temozolomide and placebo repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo advanced imaging studies including magnetic resonance spectroscopy, dynamic contrast-enhanced MRI, dynamic susceptibility-contrast MRI, and/or 3'-deoxy-3'-[18F]fluorothymidine positron emission tomography at baseline and periodically during study.

Tumor tissue samples are collected at baseline for MGMT gene methylation analysis. Blood and urine samples may also be collected at baseline and periodically during study for other correlative laboratory studies.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

cediranib maleate, temozolomide, placebo, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:09-0400

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