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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

Primary Purpose

Lymphoma, B-Cell

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring B-Cell NHL, Autologous Stem Cell Transplant, RICE

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Francisco

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2007
Last Updated
April 11, 2012
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00515138
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution. 7 patients accrued and there is insufficient data to analyze.
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
B-Cell NHL, Autologous Stem Cell Transplant, RICE

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
Intervention Description
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
Primary Outcome Measure Information:
Title
-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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence D. Kaplan, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Behler, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.ucsf.edu
Description
UCSF Cancer Center

Learn more about this trial

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

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