A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
|ClinicalTrials.gov Identifier: NCT01561833|
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : February 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|T Cell Lymphoma||Drug: Sorafenib||Phase 1|
• 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
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.
- Biological Effects of Sorafenib on ERK phosphorylation in patients with T-cell lymphoma [ Time Frame: 29 days to the baseline value ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561833
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Francine Foss, MD||Yale University|