Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * 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 antigen. * 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 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
