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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00066508
First received: August 6, 2003
Last updated: January 7, 2013
Last verified: January 2013
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

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 ]

Enrollment: 7
Study Start Date: May 2003
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00066508     History of Changes
Other Study ID Numbers: CDR0000316254, UCLA-0301090
Study First Received: August 6, 2003
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014