A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
Summary
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.
Timeline
- Start
- 2007-05
- Primary completion
- 2011-11
- Completion
- 2011-11
Outcome
Outcome not reported
Stopped (Enrollment): “Investigator left institution. 7 patients accrued and there is insufficient data to analyze.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.7 mg/m2 | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 5 mg/m2 | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |