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A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

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Trial Information

A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma


PRIMARY OBJECTIVES:

I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with
recurrent aggressive non-Hodgkin's lymphomas.

SECONDARY OBJECTIVES:

I. To evaluate the duration of response and progression free survival of treatment with
BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.

II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent
aggressive Non-Hodgkin's Lymphomas.

III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess
influence of monooxygenases polymorphisms and MDR on pharmacokinetics.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.


Inclusion Criteria:



- Patients must have histologically confirmed recurrent de novo or transformed diffuse
large B cell lymphoma (DLBCL) or one of its variants according to WHO classification
(centroblastic, immunoblastic, T-cell/histiocyte rich and anaplastic variants)

- Patients must have no CNS involvement

- ECOG performance status must be 0 or 1

- Patients must have measurable disease as defined in section 6 assessed within 4 weeks
of registration

- Patients must not have been previously treated with Sorafenib (BAY 43-9006) or other
small molecule targeted inhibitors of MAPK signaling intermediates or angiogenesis
(e.g. bevacizumab,/Avastin, oral MEK inhibitor CI-1040)

- Patients must have failed one or more prior NHL chemotherapy or antibody therapy with
curative intent; autologous stem cell transplant is permitted

- Patients must not have progressed within 60 days of last therapy

- Patients must not have received prior allogeneic stem cell transplant

- Patients must not be candidates for potentially curative therapy, such as HSCT, OR
must have refused these alternative therapies

- Patients must not be receiving any other investigational agents

- Patients must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to sorafenib

- Patients must not have uncontrolled intercurrent illness including, but not limited
to: ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that
would limit compliance with study requirements

- Leukocytes >= 2,000/mm^3

- Absolute neutrophil count >= 1,000/mm^3

- Platelets >= 75,000/ mm^3

- Total bilirubin =< 2.0 X normal institutional limits

- AST =< 2.5 X institutional upper limit of normal

- ALT =< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits; creatinine clearance calculated or
measured at >= 60 ml/min/1.73m^2 if creatinine level is above institutional limits

- PT/INR Within Institutional limits of normal

- Patients with underlying hypertension as defined by blood pressures averaging greater
than 140/90 on two separate clinic visits are eligible if hypertension has been
controlled by standard nonpharmacologic and pharmacologic therapy

- Patients must not have active HIV infection, because of possible pharmacokinetic
interactions of anti-retroviral therapy with BAY43-9006

- Patients must be physically able to orally ingest tablets

- Patients must not have any evidence of bleeding diathesis

- Patients must not be taking the cytochrome P450 enzyme-inducing anti-epileptic drugs
(phenytoin, carbamazepine and phenobarbital), rifampin or St. John's Wort

- Women must not be pregnant or breast-feeding because the side effects of BAY43-9006
on developing embryos and nursing infants are unknown; all females of childbearing
potential must have a blood test or urine study within 2 weeks prior to registration
to rule out pregnancy

Exclusion Criteria:

- Women of childbearing potential and sexually active males must be strongly advised to
use an accepted and effective method of contraception

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate based on the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Sandra Horning

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02955

NCT ID:

NCT00131937

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215