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Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066508
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: bortezomib Phase 2

Detailed Description:


  • Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the time to disease progression in patients treated with this drug.
  • Determine the possible mechanism of resistance to this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 20 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date : May 2003
Actual Primary Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

Primary Outcome Measures :
  1. Overall response rate (combined complete response and partial response)

Secondary Outcome Measures :
  1. Safety
  2. Tolerability
  3. Time to disease progression
  4. Possible mechanism of resistance

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following:

    • Relapsed after prior high-dose chemotherapy with stem cell support
    • Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support
  • Measurable disease

    • At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan
  • No primary or secondary CNS lymphoma
  • No HIV-related lymphoma
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • Hemoglobin at least 9 g/dL
  • Absolute neutrophil count at least 1,000/mm^3

    • No colony-stimulating factors within 4 weeks before obtaining this result
  • Platelet count at least 50,000/mm^3

    • No platelet transfusion within 4 weeks before obtaining this result


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • No active hepatitis B or C viral infection


  • Creatinine no greater than 2 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction within the past 6 months
  • No evidence of acute ischemia or new conduction system abnormalities on EKG
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Sodium greater than 130 mEq/L
  • HIV negative
  • No ongoing or active infection
  • No other concurrent uncontrolled illness that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib


Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy
  • At least 4 weeks since prior immunotherapy


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • More than 4 weeks since prior major surgery unless fully recovered


  • Recovered from prior therapy
  • No other concurrent investigational agents
  • No other concurrent investigational or commercial agents or therapies to treat the malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066508

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Sven De Vos, MD Jonsson Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00066508    
Other Study ID Numbers: CDR0000316254
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent adult diffuse large cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents