Vorinostat (Zolinza®) in Combination With (Velcade®) Versus Vorinostat Alone in Refractory or Recurrent Advanced CTCL: A Randomized Phase III Study.
- To determine if the combination of bortezomib plus vorinostat (SAHA) is more effective
than vorinostat alone, in terms of prolonging progression-free survival, in patients
with stage IIB-IV cutaneous T-cell lymphoma who have failed prior therapy.
- To determine the overall survival of these patients.
- To determine the response rate in these patients.
- To determine the time to progression in these patients.
- To determine the duration of response in these patients.
- To determine the incidence of second cancers in these patients.
- To determine the acute and late toxicity of this regimen in these patients.
- To determine if translational research may provide insight into disease mechanism and
identify biomarkers useful for prediction of treatment response. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to type of cutaneous
T-cell lymphoma (mycosis fungoides vs erythrodermic mycosis fungoides/Sézary syndrome),
number of prior chemotherapy regimens (1 vs ≥ 2), and country. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive oral vorinostat (SAHA) once daily in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral vorinostat once
daily on days 1-14. Treatment repeats every 21 days until progression or unacceptable
Blood and tissue samples are collected periodically for translational research to provide
insight into disease mechanism and identify biomarkers useful for prediction of treatment
After completion of study treatment, patients are followed up at 4 weeks and then every 3
months until disease progression.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Pablo Luis Ortiz-Romero
Hospital Universitario 12 de Octubre