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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center Identifier:
First received: September 15, 2005
Last updated: January 19, 2016
Last verified: January 2016

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.

Condition Intervention Phase
Lymphoma Drug: bortezomib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Resource links provided by NLM:

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate After 2 Courses of Treatment [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Time to Progression [ Time Frame: 2 years ]
  • Toxicity [ Time Frame: 2 years ]

Enrollment: 5
Study Start Date: July 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bortezomib Drug: bortezomib

Detailed Description:


  • 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.


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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00182637

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Lauren C. Pinter-Brown, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00182637     History of Changes
Other Study ID Numbers: CDR0000439458
P30CA016042 ( US NIH Grant/Contract Award Number )
Study First Received: September 15, 2005
Results First Received: January 19, 2016
Last Updated: January 19, 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents processed this record on June 23, 2017