NCT01062425

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

Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies 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 (a type of brain 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. 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.

Detailed description

PRIMARY OBJECTIVES: I. To determine if the addition of cediranib (cediranib maleate) to chemoradiation treatment enhances treatment efficacy as measured by the 6-month progression-free survival rate. SECONDARY OBJECTIVES: I. To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by overall survival. II. To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by progression-free survival. III. To determine if there is an association between tumor O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) gene methylation status and treatment response and outcome. IV. To compare and record the toxicities of the cediranib + chemoradiation arm versus the chemoradiation arm. V. To evaluate whether 6-month progression-free survival is associated with overall survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cediranib maleate orally (PO) once daily (QD) for 3 days. Patients then undergo radiation therapy (intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy) QD, 5 days a week, for 6 weeks and receive temozolomide PO QD and cediranib maleate PO QD for 6 weeks. Patients then receive temozolomide PO QD alone on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD for 3 days. Patients then undergo radiation therapy (intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy) QD, 5 days a week, for 6 weeks and receive temozolomide PO QD and placebo PO QD for 6 weeks. Patients then receive temozolomide PO QD alone on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Conditions

• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy	Undergo 3-dimensional conformal radiotherapy
DRUG	Cediranib Maleate	Given PO
RADIATION	Intensity-Modulated Radiation Therapy	Undergo intensity-modulated radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo Administration	Given PO
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2010-02-26
• Primary completion: 2015-12-06
• Completion: 2022-05-20
• First posted: 2010-02-04
• Last updated: 2022-07-26
• Results posted: 2016-09-19

Locations

105 sites across 1 country: United States