Vorinostat With or Without Bortezomib in Treating Patients With Refractory or Recurrent Stage IIB, Stage III, or Stage IV Cutaneous T-Cell Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed advanced cutaneous T-cell lymphoma (CTCL), including its variants mycosis fungoides and Sézary syndrome
• •* Stage IIB-IV disease
• •Relapsed or refractory disease, including any of the following:
• •* Patients with clinical progression following EORTC-21081 protocol treatment
• •* Intolerant to ≥ 1 prior intravenous chemotherapy, including denileukin diftitox, antibodies or antibody conjugates, or any other systemic therapy
• •No CNS involvement
• •PATIENT CHARACTERISTICS:
• •WHO performance status 0-2
• •Absolute neutrophil count \> 1.5 x 10\^9/L\*
• •Platelet count \> 100 x 10\^9/L\*
• •Hemoglobin \> 9 g/dL\*
• •WBC \> 3 x 10\^9/L\*
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
• •AST and ALT ≤ 3 times ULN (in case of liver infiltration ≤ 5 x ULN)\*
• •Serum creatinine ≤ 2.0 mg/dL\*
• •Calculated creatinine clearance ≥ 60 mL/min
• •Electrolytes (including potassium and magnesium) ≤ 1 times ULN\*
• •Not pregnant or nursing prior to the first dose of study treatment and until 4 weeks after the last study treatment
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• •Able to swallow capsules and is able to take or tolerate oral medication on a continuous basis
• •No New York Heart Association class III-IV disease
• •None of the following known conditions:
• •* Infectious disease
• •* Autoimmune disease
• •* Immunodeficiency
• •No known or active HIV and/or hepatitis A, B, or C infection
• •No NCI CTC grade 1 peripheral sensory neuropathy with pain or peripheral sensory or motor neuropathy ≥ grade II
• •No other malignancy within the past 5 years
• •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule NOTE: \*Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable, except for renal function.
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Must have completely recovered from previous treatment toxicity
• •No prior splenectomy or splenic irradiation
• •No prior bortezomib and/or histone deacetylase inhibitors (including vorinostat \[SAHA\])
• •More than 4 weeks since prior chemotherapy, immunotherapy, radiotherapy, or surgery
• •* In case of clear progression during previous treatment, 2 weeks of wash-out is enough
• •No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery (except biopsies)
• •No concurrent steroid (prednisone or equivalent) dose \> 20 mg/day
• •* Prednisone ≤ 20 mg/day for treatment of disorders other than CTCL allowed
• •No concomitant use of other histone deacetylase inhibitors (e.g., valproic acid)