Tridion Support | Component and Template Instructions | External Applications | Clinical Trials Listing | Details

A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-cell Lymphoma Patients

Conditions

Anaplastic Large Cell Lymphoma (ALCL) | Angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) | Lymphoma, T-Cell, Cutaneous | Lymphoma, T-Cell, Peripheral | other transformed T-cell lymphomas

What is the purpose of this trial?

Primary objectives:

·        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.

Secondary objectives:

  • 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.

Exploratory objectives:

  • 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.

Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.

Sponsor:
Bayer
Yale Cancer Center
Dates:
October 2009
Last Updated:
Study HIC#:
0901004690

Clinicaltrials.gov ID: Yale5062786