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

This is an interventional treatment trial for Lymphoma focused on measuring stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, 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 mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma Read More

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)