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A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas

Phase 2
18 Years
Not Enrolling
Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas


I. Determine the overall response rate, including complete and partial responses, in
patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with


I. Determine progression-free and overall survival of patients treated with this drug.

II. Determine response duration in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral sorafenib twice daily in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Inclusion Criteria:

- Histologically or cytologically confirmed aggressive* non-Hodgkin's lymphoma by
excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of
the following types:

- Mantle cell lymphoma

- Primary mediastinal large B-cell lymphoma

- Diffuse large B-cell lymphoma

- Anaplastic large cell lymphoma (T-cell or null-cell type)

- Recurrent disease

- Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g.,
CHOP [with or without rituximab] or R-EPOCH)

- Chemosensitive disease at the time of relapse

- Patients who responded with a complete or partial remission that lasted at least
8 weeks after their last chemotherapy regimen are considered chemosensitive

- Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest
transverse diameter on CT scan

- Ineligible for, refused, or relapsed after stem cell transplant (for patients with
non-mantle cell lymphoma)

- No known brain metastases, including meningeal involvement

- ECOG performance status (PS) 0-2

- Karnofsky PS 60-100%

- Life expectancy > 3 months

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Fertile patients must use effective contraception

- Not pregnant or nursing

- Negative pregnancy test

- No uncontrolled illness

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to sorafenib

- No known positive HIV serology

- No inflammatory bowel disease

- No swallowing dysfunction that would prevent ingestion of pills

- No hemorrhagic diathesis

- No ongoing or active infection

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No uncontrolled hypertension

- No psychiatric or social situation that would limit compliance with study

- No poorly controlled medical condition that would seriously complicate compliance
with this study

- Patients with inflammatory or exfoliative skin disease are excluded (regardless of
the extent of the involvement) unless the skin condition is lymphoma related

- See Disease Characteristics

- Previous treatment-related toxic effects should be resolved to grade 1 or better

- No chemotherapy or radiation therapy within the past 4 weeks

- 6 weeks for nitrosoureas or mitomycin C

- No prior antibody therapy for at least 3 months

- Prior radiation for localized disease or total body irradiation as part of a
conditioning regimen prior to stem cell transplant allowed

- Prior radio-immunotherapy allowed

- No concurrent therapeutic anticoagulation

- Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial
access devices are acceptable provided that the requirements for PT, INR, and
PTT are met

- No concurrent use of another investigational agent

- No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital,
rifampin, or Hypericum perforatum (St. John's wort)

- No other concurrent anticancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate (complete and partial response)

Outcome Description:

Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Meyer Heyman

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell



University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201