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.

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.

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

From the time that subjects signed consent until 30 days post treatment. Time frame varied depending on the time that the subject was on study. Approximately 6-7 months.