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

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