Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors.
Brain and Central Nervous System Tumors
Procedure: conventional surgery
Radiation: iodine I 131 monoclonal antibody 81C6
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors|
|Study Start Date:||October 1997|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- Determine which one of two delivery techniques (bolus injection versus microinfusion) provides the greater distribution volume of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) administered intratumorally in patients with newly diagnosed or recurrent malignant primary brain tumors.
- Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in these patients.
- Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients.
OUTLINE: This is a randomized, dose-escalation study.
Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by the other technique 3 days later. Each patient then receives a therapeutic dose by the most efficient method. Both methods are delivered via a stereotactically-placed intralesional catheter.
- Arm I: Bolus injection method
- Arm II: Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6, with dose escalation occurring separately for each arm. After 10 patients are enrolled and the best method of administration is determined, all subsequent patients receive I 131 MAb 81C6 by that method, and the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more the 2 of 6 patients experience dose-limiting toxicity.
Patients with newly diagnosed tumors for which no effective conventional therapy exists, such as malignant glial tumors, are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy unless tumor progresses.
Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year.
PROJECTED ACCRUAL: At least 10 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003478
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Darell D. Bigner, MD, PhD||Duke Cancer Institute|