- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131937
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
Study Overview
Status
Conditions
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Peripheral T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Hepatosplenic T-cell Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Eastern Cooperative Oncology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
- Eastern Cooperative Oncology Group (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 have failed one or more prior Non-Hodgkin lymphoma (NHL) chemotherapy or antibody therapy with curative intent; autologous stem cell transplant is permitted
- 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
- Aspartate Aminotransferase (AST) =< 2.5 X institutional upper limit of normal
- Alanine Aminotransferase (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
- The prothrombin time (PT)/international normalized ratio (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 be physically able to orally ingest tablets
Exclusion Criteria:
- Central nervous system (CNS) involvement
- Previously treated with Sorafenib (BAY 43-9006) or other small molecule targeted inhibitors of mitogen-activated protein kinase (MAPK) signaling intermediates or angiogenesis (e.g. bevacizumab)
- Progressed within 60 days of last therapy
- Prior allogeneic stem cell transplant
- Candidates for potentially curative therapy, such as hematopoietic stem cell transplantation (HSCT)
- Currently receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
- 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
- Active HIV infection, because of possible pharmacokinetic interactions of anti-retroviral therapy with BAY43-9006
- Evidence of bleeding diathesis
- Currently taking the cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine and phenobarbital), rifampin or St. John's Wort
- Pregnant or Breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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. |
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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:
|
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
|
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.
|
Overall survival is defined as the time from study entry until death from any cause.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandra Horning, Eastern Cooperative Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Leukemia, Lymphoid
- Leukemia
- Lymphoma, B-Cell
- Lymphadenopathy
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Recurrence
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma, Large-Cell, Anaplastic
- Immunoblastic Lymphadenopathy
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- NCI-2014-00658
- U10CA021115 (U.S. NIH Grant/Contract)
- E1404 (Other Identifier: Eastern Cooperative Oncology Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Adult Diffuse Large Cell Lymphoma
-
National Cancer Institute (NCI)CompletedRecurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Recurrent Adult Immunoblastic Large Cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Adult Diffuse Large Cell LymphomaCanada
-
Xinqiao Hospital of ChongqingXuzhou Medical University; Shanghai Changzheng Hospital; Hrain Biotechnology...UnknownRecurrent Adult Diffuse Large Cell Lymphoma | Recurrent Mantle Cell Lymphoma | Stage III Adult Diffuse Large Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Recurrent Follicular Lymphoma | Stage III Follicular Lymphoma | Stage...China
-
National Cancer Institute (NCI)CompletedRecurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Anaplastic Large Cell LymphomaUnited States
-
Case Comprehensive Cancer CenterActive, not recruitingStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Sunnybrook Health Sciences CentreMerck Sharp & Dohme LLC; ImmunoVaccine Technologies, Inc. (IMV Inc.)CompletedRecurrent | Adult Diffuse Large Cell Lymphoma | Adult Refractory Diffuse Large B-Cell LymphomaCanada
-
University of NebraskaNational Cancer Institute (NCI); Genta IncorporatedTerminatedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Fox Chase Cancer CenterGenentech, Inc.WithdrawnStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Xinqiao Hospital of ChongqingXuzhou Medical UniversityUnknownRecurrent Adult Diffuse Large Cell Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Follicular Lymphoma | Stage III/IV Adult Diffuse Large Cell Lymphoma | Stage III/IV Follicular Lymphoma | Stage III/IV Mantle Cell LymphomaChina
-
National Cancer Institute (NCI)CompletedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell LymphomaUnited States
Clinical Trials on sorafenib tosylate
-
National Cancer Institute (NCI)CompletedMultiple Endocrine Neoplasia Type 2A | Multiple Endocrine Neoplasia Type 2B | Recurrent Thyroid Gland Medullary Carcinoma | Hereditary Thyroid Gland Medullary Carcinoma | Locally Advanced Thyroid Gland Medullary Carcinoma | Sporadic Thyroid Gland Medullary Carcinoma | Stage III Thyroid Gland Medullary... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingGastrointestinal Stromal TumorUnited States
-
National Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndrome | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Secondary Myelodysplastic Syndrome | de Novo Myelodysplastic Syndrome | Adult Acute Monoblastic Leukemia | Adult Acute Monocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Ovarian Carcinoma | Primary Peritoneal CarcinomaUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterBayerTerminated
-
National Cancer Institute (NCI)CompletedJuvenile Myelomonocytic Leukemia | Recurrent Disease | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Childhood Solid Neoplasm | Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Philadelphia... and other conditionsUnited States, Canada
-
National Cancer Institute (NCI)CompletedAdvanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedHilar Cholangiocarcinoma | Recurrent Gallbladder Carcinoma | Unresectable Extrahepatic Bile Duct Carcinoma | Unresectable Gallbladder Carcinoma | Gallbladder Adenocarcinoma | Recurrent Extrahepatic Bile Duct Carcinoma | Extrahepatic Bile Duct Adenocarcinoma | Gallbladder Adenocarcinoma With Squamous... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedNon-Small-Cell Lung CarcinomaUnited States