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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bortezomib<br> | Drug: bortezomib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate After 2 Courses of Treatment |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | 2 years | 
| Toxicity |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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