Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
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
Drug: sorafenib tosylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma|
- Overall Response (OR) Rate [ Time Frame: Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years. ] [ Designated as safety issue: No ]
Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.
PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites.
- Progression-Free Survival (PFS) [ Time Frame: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years ] [ Designated as safety issue: No ]
PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:
- Appearances of any new lesions/sites during or after therapy
- Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site
- Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis
- Overall Survival [ Time Frame: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years. ] [ Designated as safety issue: No ]Overall survival is defined as the time from study entry until death from any cause.
|Study Start Date:||October 2005|
|Study Completion Date:||August 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with recurrent aggressive non-Hodgkin's lymphomas.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131937
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sandra Horning||Eastern Cooperative Oncology Group|