Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immu-LL2: Treatment With 90Y-hLL2 IgG
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y
90-labeled humanized anti-CD22 monoclonal antibody LL2(90Y-hLL2 IgG) in patients with B-cell
malignancies. II. Determine the pharmacokinetics and biodistribution of indium In 111
humanized LL2 (111In-hLL2 IgG) in these patients. III. Evaluate the immunogenicity of
repeated injections of 90Y-hLL2 IgG in these patients. IV. Determine whether 90Y-hLL2 IgG
versus indium In 131 humanized LL2 IgG has a therapeutic advantage based on organ and tumor
dosimetry obtained with 111In-hLL2 IgG.
OUTLINE: This is a dose escalation study. Patients are stratified into risk groups (high vs
low). Patients receive pretherapy imaging with indium In 111 humanized LL2 IgG IV for up to
30 minutes on days -7 to 0. Patients receive yttrium Y 90-labeled humanized anti-CD22
monoclonal antibody LL2 (90Y-hLL2-IgG) IV for up to 30 minutes on day 0. Cohorts of 3-6
patients receive escalating doses of 90Y-hLL2-IgG until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding the dose at which 2 of 3 or 2 of 6
patients experience dose limiting toxicity. Patients are followed every 2 weeks for 1 month,
monthly for 2 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1-2
years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerated dose
12 weeks
No
Jack D. Burton, MD
Study Chair
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
United States: Federal Government
CDR0000067295
NCT00004084
April 1998
Name | Location |
---|---|
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Garden State Cancer Center | Belleville, New Jersey 07103 |