Brain and Central Nervous System Tumors Clinical Trial
Official title:
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
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the
immune system in different ways and stop tumor cells from growing. Drugs used in
chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. It is not yet known
whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating
patients with glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying the side effects and how well
lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with
newly diagnosed glioblastoma multiforme that can be removed by surgery.
OBJECTIVES:
- 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
treatment arms.
- 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 craniotomy.
After completion of study treatment, patients are followed periodically for up to 5 years.
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