Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma

July 30, 2020 updated by: Jonsson Comprehensive Cancer Center

A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label 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.

After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome
  • Stage IB-IV disease
  • Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy
  • Measurable disease by radiological imaging or clinical finding
  • Age Over 18
  • Performance status Karnofsky 70-100%

  • Hematopoietic

    • WBC > 2,000/mm^3
    • Absolute neutrophil count > 1,500/mm^3
    • Platelet count > 75,000/mm^3
    • Hemoglobin > 8.0 g/dL

  • Hepatic

    • Bilirubin < 2 times upper limit of normal (ULN)
    • AST and ALT < 3 times ULN

  • Renal

    • Creatinine < 1.5 times ULN
    • Creatinine clearance ≥ 30 mL/min
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 3 months since prior high-dose chemotherapy
  • More than 30 days since prior and no other concurrent investigational drugs

Exclusion Criteria:

  • history of myelodysplastic syndromes
  • evidence of CNS disease
  • pregnant or nursing
  • peripheral neuropathy ≥ grade 2
  • hypersensitivity to bortezomib, boron, or mannitol
  • serious medical condition or psychiatric illness that would preclude study participation
  • concurrent immunotherapy
  • concurrent chemotherapy
  • concurrent steroid dose > 10 mg/day of prednisone or its equivalent
  • concurrent radiotherapy
  • concurrent surgery for the malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bortezomib
Drug: bortezomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate After 2 Courses of Treatment
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: 2 years
2 years
Toxicity
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Lauren C. Pinter-Brown, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000439458
  • UCLA-0405014-02
  • MILLENNIUM-VEL-04-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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