Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
|ClinicalTrials.gov Identifier: NCT00003461|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Metastatic Cancer Neuroblastoma||Procedure: surgical procedure Radiation: astatine At 211 monoclonal antibody 81C6||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Primary Completion Date :||February 2005|
|Study Completion Date :||February 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|