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

NCT00515138 | Terminated Early Phase 1 DMC

• 1 other identifier: UC-CC06253
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, B-Cell

Keywords

B-Cell NHL; Autologous Stem Cell Transplant; RICE

Outcome Measures

Primary Outcomes (1)

• -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

  3 years

Interventions

Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib DRUG

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Links

• UCSF Cancer Center

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab; Ifosfamide; Carboplatin; Etoposide; Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Lawrence D. Kaplan, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Caroline Behler, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

US (1)