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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00515138 |
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.
Condition | Intervention | Phase |
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Lymphoma, B-Cell |
Drug: Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 22 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Aggressive B-Cell Lymphoma, CD-20 positive, in first relapse or refractory to first-line chemotherapy
Exclusion Criteria:
Contact: Beth Davis, C.C.R.A. | 415-502-3176 | bdavis@medicine.ucsf.edu |
Contact: Natalie J. Jeha, M.A. | 415-476-4126 | njeha@medicine.ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Beth Davis, C.C.R.A. 415-502-3176 bdavis@medicine.ucsf.edu | |
Principal Investigator: Lawrence D. Kaplan, M.D. | |
Principal Investigator: Caroline Behler, M.D. | |
Sub-Investigator: Charles A. Linker, M.D. | |
Sub-Investigator: Lloyd Damon, M.D. | |
Sub-Investigator: Jeffrey L. Wolf, M.D. | |
Sub-Investigator: Thomas G. Martin, M.D. | |
Sub-Investigator: Wei Ai, M.D. | |
Sub-Investigator: Karin Gaensler, M.D. | |
Sub-Investigator: Peter Sayre, M.D. |
Principal Investigator: | Lawrence D. Kaplan, M.D. | University of California, San Francisco |
Principal Investigator: | Caroline Behler, M.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( University of California, San Francisco ) |
Study ID Numbers: | UC-CC06253 |
Study First Received: | August 9, 2007 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00515138 |
Health Authority: | United States: Food and Drug Administration |
B-Cell NHL Autologous Stem Cell Transplant RICE |
Immunoproliferative Disorders Rituximab Bortezomib Lymphoma, small cleaved-cell, diffuse Carboplatin Etoposide phosphate Lymphoma, B-Cell Lymphatic Diseases Ifosfamide |
Mechlorethamine B-cell lymphomas Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Mesna Lymphoma Etoposide Isophosphamide mustard |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions |
Protease Inhibitors Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |