NCT00574964

Gliadel Wafers and Temodar in the Treatment of Glioblastoma Multiforme

Phase II Treatment of Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme Treated With Gliadel Wafers, Surgery and Limited Field Radiation Plus Concomitant Temozolomide Followed by Temozolomide

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if combining all three treatments of Gliadel wafers, Temozolomide and Radiation therapy at the same time is safe and more effective than one treatment at a time. The study will measure the survival of subjects treated with this combination of drugs.

Detailed description

Subjects will receive surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy to a dose of 61.2 Gy with concomitant daily temozolomide. Up to 8 wafers will be implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between days 10 and 30 all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin, with concomitant daily temozolomide (75mg/m2 x 7 d/wk for 6 weeks, concomitant chemoradiotherapy phase). Beginning no later than 45 days following completion of radiation, temozolomide will be given at a dosage of 200 mg/m2 daily for five days on a 28 day schedule, for a total of 6 cycles (adjuvant chemotherapy phase). Subjects will be monitored weekly during chemoradiotherapy with CBC with differential and brief clinical assessment, and monthly during the adjuvant chemotherapy phase. Toxicity reports will be assessed every three months. Dose limiting toxicities (DLT) are defined in section 4.2. If toxic events unresponsive to planned dose modification exceed 20% of enrolled subjects the stopping rule will be met and the study will be discontinued. MRIs will be obtained no more than 72 hours post-op, and then prior to the first, third, and fifth cycles of monthly temozolomide. Additionally, a stealth MRI or CT scan (with or without contrast) will be done one week prior to radiotherapy for treatment planning at the discretion of the treating Radiation Oncologist. Following completion of the entire course of treatment subjects will be monitored clinically as well as with MRI every 3 months for survival and evidence of progression.

Conditions

• Primary Glioblastoma Multiforme

Interventions

Type	Name	Description
OTHER	Gliadel Wafer, Temodar and Radiotherapy	Given concurrently starting 10-30 days after surgery.

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-11-01
• Completion: 2008-06-01
• First posted: 2007-12-17
• Last updated: 2016-10-27

Locations

1 site across 1 country: United States