A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-cell Lymphoma Patients
What is the purpose of this trial?
· To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein kinase (MAPK) pathway, specifically the inhibition of ERK phosphorylation, and to correlate with clinical activity in patients with T-cell lymphoma.
- 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, and Syk.
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.
- 18 Years and older
Yale Cancer Center
- October 2009
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale5062786