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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT00515138
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib — DRUG
    Bortezomib starting at 1 mg/m(2), and escalating to 1.3, 1.5, 1.7. Bortezomib will be given on Days 1 (prior to rituximab) and 4, rituximab at 375 mg/m(2) on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 mg/m(2), on day 3 and etoposide 100 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

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Apr 2012
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

-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 NHL [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-

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