Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Experimental
bortezomib