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
- 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
- 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
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
Primary Purpose: Treatment
Darell D. Bigner, MD, PhD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|