A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients|
- Biological Effects of Sorafenib on ERK phosphorylation in patients with T-cell lymphoma [ Time Frame: 29 days to the baseline value ] [ Designated as safety issue: No ]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.
- Objective response rate of patients following initial treatment with sorafenib and progression free survival [ Time Frame: 8 weeks following initial treatment ] [ Designated as safety issue: No ]Patients with stable disease (SD), complete or partial response (CRIPR) lasting at least 8 weeks would be considered to have a meaningful clinical effect from sorafenib.
|Study Start Date:||October 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Sorafenib, 400 mg PO twice daily
Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.
• 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561833
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Francine Foss, MD||Yale University|