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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 is currently recruiting participants.
Verified by University of California, San Francisco, May 2008
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00515138
  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

MedlinePlus related topics: Lymphoma
Drug Information available for: Mesna Ifosfamide Carboplatin Filgrastim Etoposide Rituximab Etoposide phosphate Pegfilgrastim Bortezomib
U.S. FDA Resources
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

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 ]

Estimated Enrollment: 22
Study Start Date: May 2007
Estimated Primary Completion Date: May 2010 (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

Contacts
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

Locations
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.            
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

UCSF Cancer Center  This link exits the ClinicalTrials.gov site

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

Keywords provided by University of California, San Francisco:
B-Cell NHL
Autologous Stem Cell Transplant
RICE

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009