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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


Phase 0
18 Years
70 Years
Not Enrolling
Both
Lymphoma, B-Cell

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Lawrence D. Kaplan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

UC-CC06253

NCT ID:

NCT00515138

Start Date:

May 2007

Completion Date:

November 2011

Related Keywords:

  • Lymphoma, B-Cell
  • B-Cell NHL
  • Autologous Stem Cell Transplant
  • RICE
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

University of California San FranciscoSan Francisco, California  941104206