PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled
monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with
neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to
this treatment.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2,
131I-Me1-14 F(ab')2.
PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied.
Interventional
Primary Purpose: Treatment
Darell D. Bigner, MD, PhD
Study Chair
Duke University
United States: Federal Government
1193
NCT00002751
July 1989
May 2004
Name | Location |
---|---|
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |