Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Biological: bispecific antibody MDX447 Biological: lymphokine-activated killer cells Procedure: conventional surgery||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme|
|Study Start Date:||March 1997|
|Study Completion Date:||January 2003|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
- Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
- Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.
OUTLINE: This is a dose escalation study.
Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.
Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005813
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Principal Investigator:||Camilo E Fadul, MD||Dartmouth-Hitchcock Medical Center|