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


N/A
18 Years
85 Years
Open (Enrolling)
Both
T Cell Lymphoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biological Effects of Sorafenib on ERK phosphorylation in patients with T-cell lymphoma

Outcome Description:

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.

Outcome Time Frame:

29 days to the baseline value

Safety Issue:

No

Principal Investigator

Francine Foss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

0901004690

NCT ID:

NCT01561833

Start Date:

October 2009

Completion Date:

July 2013

Related Keywords:

  • T Cell Lymphoma
  • relapsed or refractory T cell lymphoma
  • Lymphoma
  • Lymphoma, T-Cell

Name

Location
Yale Cancer Center New Haven, Connecticut  06520-8028