A Phase I/II Trial of Combination Bortezomib (VELCADE) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma
- 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.
- 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,
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate (combined complete remission [CR] and partial remission [PR])of the combination of study drugs in patients with relapsed or refractory B- and T-cell NHL
Disease evaluations to evaluate the response rate of the combination of study drugs in patients with relapsed or refractory B- and T-cell NHL will be done by CT scan at screening and after completing cycle 3, cycle 6 and 30 days after cycle 8.
At screening and after completing cycle 3, cycle 6 and 30 days after cycle 8
Leo Gordon, MD
United States: Food and Drug Administration
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Northwestern University||Chicago, Illinois 60611|