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
Northwestern University
With
OBJECTIVES: Primary * Determine the response rate (complete and partial remission) in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkin's lymphoma treated with gemcitabine hydrochloride and bortezomib. * Determine the maximum tolerated dose of bortezomib when administered with gemcitabine hydrochloride in these patients. Secondary * Determine the time to treatment failure, duration of response, and overall survival of patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II, open-label study. * Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity (DLT) OR the dose that at which 2 of 6 patients experience DLT. * Phase II: Patients receive gemcitabine hydrochloride and bortezomib as in phase I at the MTD. After completion of study therapy, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
