Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma
- To compare the side effects, including infections and/or abnormal healing at the
surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs
polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for
patients with newly diagnosed resectable glioblastoma multiforme.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: Patients are stratified according to age (< 50 vs ≥ 50 years of age), Karnofsky
performance status (70-80% vs 90-100%), use of corticosteroids > 4 mg/day (yes vs no), and
progressive disease during first-line therapy (yes vs no). Patients are randomized to 1 of 2
- Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine
implant (Gliadel® wafer) at the time of therapeutic craniotomy.
- Arm II: Patients undergo leukapheresis to obtain autologous lymphokine-activated killer
(LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK
cells are then instilled into the tumor bed cavity at the time of therapeutic
After completion of study treatment, patients are followed periodically for up to 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Robert O. Dillman, MD, FACP
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
|Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian||Newport Beach, California 92663|