Preoperative Chemoradiation for Glioblastoma

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

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

Details

• Lead Sponsor: Tampa General Hospital
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)

• WHO performance status 0-2 (to allow comparison to historical controls)

• Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)

• Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)

• Able to have MRI scans (secondary endpoint is MRI scan characteristics)

• Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)

• Ages 18-80

Exclusion Criteria:

• Unresectable tumor

• Absolute neutrophil count (ANC) less than 1,200/μL

• Hemoglobin less than 9.0g/dL

• Platelet count less than 100,000/μL