Trials / Completed
CompletedNCT00131937
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed description
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 multi-drug resistance transporter (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. PLANNED ACCRUAL: 41 ACTUAL ACCRUAL: 14
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sorafenib tosylate | Given orally |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2011-09-01
- Completion
- 2012-08-01
- First posted
- 2005-08-19
- Last updated
- 2015-09-03
- Results posted
- 2015-09-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00131937. Inclusion in this directory is not an endorsement.