NCT00052208

Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of gefitinib when given together with radiation therapy and to see how well it works in treating patients with glioblastoma multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving gefitinib together with radiation therapy may be an effective treatment for glioblastoma multiforme.

Detailed description

PRIMARY OBJECTIVES: I. To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy. II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status. III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839. SECONDARY OBJECTIVES: I. Whether ZD 1839 also improves progression-free survival in these patients. OUTLINE: This is a phase I, dose-escalation study of gefitinib followed by a phase II study. Patients receive gefitinib orally (PO) once daily (QD) for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo radiation therapy QD 5 days a week for 6 weeks. Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and annually thereafter.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma

Interventions

Type	Name	Description
DRUG	gefitinib	Given PO
RADIATION	radiation therapy	Undergo radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-03-01
• Primary completion: 2005-06-01
• First posted: 2003-01-27
• Last updated: 2020-10-30

Locations

1 site across 1 country: United States