LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients who have leptomeningeal metastases metastases.
|Brain and Central Nervous System Tumors||Biological: LMB-7 immunotoxin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Protocol for a Phase I Study of Intrathecal LMB-7 (Single-Chain Immunotoxin Constructed From Monoclonal Antibody B3-Pseudomonas Exotoxin PE 38) [IND 5863, NSC 658931] in the Treatment of Patients With Leptomeningeal Neoplasms|
|Study Start Date:||September 1997|
|Study Completion Date:||September 2000|
|Primary Completion Date:||September 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the toxicity of intrathecal LMB-7 immunotoxin in patients with leptomeningeal metastases. II. Identify objective therapeutic responses in this group of patients.
OUTLINE: This is a dose escalation study. Patients receive LMB-7 intrathecally on days 1, 3, and 5. Treatment may be repeated every 4 weeks if the patient does not demonstrate HAMA neutralizing antibodies to PE-38 in CSF, has stable or responding disease, and has not experienced greater than grade II toxicity. Three to six patients are entered at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience grade 3 or worse toxicity or a neuroradiology toxicity score of 10 or greater.
PROJECTED ACCRUAL: Approximately 15 to 24 patients will be accrued over one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003020
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Chair:||Darell D. Bigner, MD, PhD||Duke Cancer Institute|