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
This study has been terminated.
(Investigator left institution. 7 patients accrued and there is insufficient data to analyze.)
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00515138
First received: August 9, 2007
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
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 |
|---|---|---|
|
Lymphoma, B-Cell |
Drug: Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ifosfamide
Etoposide
Carboplatin
Etoposide phosphate
Rituximab
Bortezomib
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- -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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 7 |
| Study Start Date: | May 2007 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Aggressive B-Cell Lymphoma, CD-20 positive, in first relapse or refractory to first-line chemotherapy
- Diffuse large B-cell Lymphoma, Mantle cell lymphoma, Follicular lymphoma (Grade III), Transformed Follicular Lymphoma
- Rituximab is allowed
- Prior radiation is allowed
- 18-70 years of age
- ECOG performance status of 0-2
- HIV seronegative
- Measurable disease on CT scan by international working group response criteria
- No CNS involvement
- Subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
- Male subject agrees to use an acceptable method of contraception for the duration of the study
Exclusion Criteria:
- Platelet count of <75 x 10(9)/L
- Absolute neutrophil count of <1.0 x 10(9)/L
- Calculated or measured creatinine clearance of <60 mL/minute within 14 days before enrollment
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Subject has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding.
- Subject has been treated with more than one prior chemotherapy regimen.
- Subject has received other investigational drugs with 14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515138
Locations
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Lawrence D. Kaplan, M.D. | University of California, San Francisco |
| Principal Investigator: | Caroline Behler, M.D. | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00515138 History of Changes |
| Other Study ID Numbers: | UC-CC06253 |
| Study First Received: | August 9, 2007 |
| Last Updated: | April 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
B-Cell NHL Autologous Stem Cell Transplant RICE |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide Etoposide phosphate Isophosphamide mustard Rituximab Bortezomib |
Ifosfamide Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013