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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00182637
First received: September 15, 2005
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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:

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182637

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

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00182637     History of Changes
Other Study ID Numbers: CDR0000439458, P30CA016042, UCLA-0405014-02, MILLENNIUM-VEL-04-103
Study First Received: September 15, 2005
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
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 17, 2014