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CompletedNCT00066508Updated Jan 8, 2013

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

A Phase 2 interventional study of bortezomib in Lymphoma, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-08.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
7
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

Keywords

  • recurrent adult diffuse large cell lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
7 participants (actual)

Interventions

  • Drugbortezomib
06

What researchers measure

Primary outcomes

  1. Overall response rate (combined complete response and partial response)

Secondary outcomes

  1. Safety

  2. Tolerability

  3. Time to disease progression

  4. Possible mechanism of resistance

07

Study locations

1 site
  • Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California 90095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00066508
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Aug 7, 2003
Start date
May 2003
Primary completion
Jul 2005
Last update
Jan 8, 2013

Study contacts

Sven De Vos, MD
study chair · Jonsson Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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