Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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 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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014