Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.
Brain and Central Nervous System Tumors
Procedure: surgical procedure
Radiation: astatine At 211 monoclonal antibody 81C6
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors|
|Study Start Date:||February 1998|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.
- Identify objective therapeutic responses of these patients to this treatment.
OUTLINE: This is a dose escalation study.
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.
Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003461
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Darell D. Bigner, MD, PhD||Duke Cancer Institute|