Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

• Status: Completed
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision

• The tumor must be supratentorial in location

• The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume

• Age ≥ 18 years

• Life expectancy of at least 12 weeks

• Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria:

• Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields

• Tumor foci detected below the tentorium

• Multifocal disease or leptomeningeal spread

• Prior allergic reaction to the study drugs involved in this protocol

• Patients with pacemaker will be allowed to undergo CT instead of MRI

• Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded