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

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Brief Title

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

Official Title

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

Brief Summary

      This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell
      lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy
      (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other
      transformed T-cell lymphomas with the primary objective of studying the biological effects of
      the multikinase inhibitor, sorafenib.
    

Detailed Description

      Primary objectives:

      • 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.

      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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Overall Response Rate


Condition

T Cell Lymphoma

Intervention

Sorafenib

Study Arms / Comparison Groups

 Sorafenib
Description:  Sorafenib, 400 mg PO twice daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

October 2009

Completion Date

June 2013

Primary Completion Date

May 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and
             Alk-), and other transformed T-cell lymphomas

          -  Age > 18 years old

          -  Measureable disease, as defined by the Cheson criteria

          -  ECOG Performance Status of 0 or 1

          -  Life expectancy > 12 weeks

          -  Adequate bone marrow, liver and renal function

          -  Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets
             50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by
             T-cell lymphoma will also be eligible

        Exclusion Criteria:

          -  Prior treatment with sorafenib, or other agents with similar activity, i.e.
             bevacizumab, imatinib, sunitinib.

          -  Prior treatment with allogeneic stem cell transplant

          -  Cardiac disease: Congestive heart failure > class II NYHA.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Francine Foss, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01561833

Organization ID

0901004690


Responsible Party

Sponsor

Study Sponsor

Yale University


Study Sponsor

Francine Foss, MD, Principal Investigator, Yale University


Verification Date

March 2020