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Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182637
  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 II

MedlinePlus related topics: Cancer Fungal Infections Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate after 2 courses of treatment [ Designated as safety issue: No ]

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

Estimated Enrollment: 25
Study Start Date: July 2004
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

DISEASE CHARACTERISTICS:

  • 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
  • No history of myelodysplastic syndromes
  • No evidence of CNS disease

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

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

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No serious medical condition or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • More than 3 months since prior high-dose chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent steroid dose > 10 mg/day of prednisone or its equivalent

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • No concurrent surgery for the malignancy

Other

  • More than 30 days since prior and no other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182637

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Lauren C. Pinter-Brown, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000439458, UCLA-0405014-02, MILLENNIUM-VEL-04-103
Study First Received: September 15, 2005
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00182637  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Bortezomib
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009