A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
• To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein
kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases
(ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell
- To observe the clinical activity of sorafenib 400mg BID by determining response rate,
and progression free survival in patients with T-cell lymphoma. Duration of response
and duration of stable disease will also be measured.
- To determine the tolerability of sorafenib in patients with T-cell lymphoma.
- To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and
the effects of sorafenib on the monocytoid population.
- To observe the effects of sorafenib on the serum cytokine profile.
- To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70,
- To observe changes in lymph node or skin morphology including tumor cell infiltrate,
vasculature, and the tumor microenvironment in patients treated with sorafenib by
performing serial biopsies of lymph nodes or skin.
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biological Effects of Sorafenib on ERK phosphorylation in patients with T-cell lymphoma
A paired t-test will be used to compare the actual values if these appear to be normally distributed. Otherwise a nonparametric sign test will be used, treating the difference of every patient's baseline to their day 29 value as a toss of a fair coin.
29 days to the baseline value
Francine Foss, MD
United States: Institutional Review Board
|Yale Cancer Center||New Haven, Connecticut 06520-8028|