A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma
- Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody
mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of
this drug in these patients.
- Determine whether clinical responses in these patients occur at lower, equal, or higher
doses than historical responses induced by a similar drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to number of
circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5.
Patients achieving complete, partial, or minimal remission receive additional courses of
therapy every 4 weeks in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of
3 or 2 of 6 patients experience dose-limiting toxicity.
Patients achieving complete remission or stable partial remission are followed every 3
months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Edward A. Sausville, MD, PhD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Research||Bethesda, Maryland 20892|