Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
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.
Adult Giant Cell Glioblastoma
Radiation: radiation therapy
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose of gefitinib defined as the dose at which no patients develop acute grade 5 toxicity and less than 30% of patients developed acute dose limiting toxicity graded by the National Cancer Institute Common Toxicity Criteria v2.0 [ Time Frame: Within 90 days from the start of radiotherapy treatment ] [ Designated as safety issue: Yes ]
- Rate of late toxicities associated with gefitinib and standard cranial radiation, graded according to the NCI CTC v2.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
- Overall survival, by EGFR status [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gefitinib, radiation therapy)
Patients receive gefitinib PO 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.
Other Names:Radiation: radiation therapy
Undergo radiation therapy
Other Names:Other: laboratory biomarker analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052208
|United States, Pennsylvania|
|Radiation Therapy Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Arnab Chakravarti||Radiation Therapy Oncology Group|