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Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
This study has been completed.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066508
  Purpose

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 Intervention Phase
Lymphoma
Drug: bortezomib
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (combined complete response and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Possible mechanism of resistance [ Designated as safety issue: No ]

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • 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

Hepatic

  • 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

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

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

Other

  • Recovered from prior therapy
  • No other concurrent investigational agents
  • No other concurrent investigational or commercial agents or therapies to treat the malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066508

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Sven De Vos, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000316254, UCLA-0301090
Study First Received: August 6, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00066508  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma

Study placed in the following topic categories:
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell lymphomas
Bortezomib
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009