SWOG clinical trial number
S0108
Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Closed
Phase
Accrual
87%
Published
Research committees
Lymphoma
Treatment
Bevacizumab
Eligibility Criteria Expand/Collapse
Biopsy proven relapsed (first or second relapse) non-Hodgkin's lymphoma (NHL) aggressive histology of one of the following histological subtypes. Transformed non-Hodgkin's Lymphoma patients are not eligible for this study: diffuse large B-cell (formerly Working Formulation Groups F, G, H), high-grade B-cell, Burkitt's or Burkitt-like; primary mediastinal; anaplastic large cell or mantle cell; patients at first relapse must not be suitable for transplant or aggressive treatment; measurable disease; chest x-ray/CT scan of chest and CT scan of abdomen/pelvis; bone marrow aspirate and biopsy; 1 or 2 prior chemo regimens completed at least 2 weeks before registration; This includes investigational agents and/or other antibody therapies.prior rituximab therapy completed at least 12 weeks before registration; If rituximab is given as a single agent after relapse, it is considered a separate regimen and will be counted as such. If rituximab is given in combination for either the first or second relapse or as consolidation after a chemotherapy regimen without an intervening relapse, it will be considered part of combination regimen and counted as one prior therapy. no major surgery within 4 weeks of registration; no radiotherapy within 2 weeks of registration; no oral sterioids; no chronic use of oral or parenteral anticoagulants (other than that used to maintain patency of an indwelling IV catheter) or anti-platelet therapy > 325 mg per day of aspirin; no acute healing bone fracture; no history of uncontrolled seizures; plasma, whole blood, urine and unstained diagnostic paraffin slides to be submitted for correlative studies; no central nervous system involvement with lymphoma; age >= 18 years; ANC >= 500; platelets >= 75,000; hematocrit >= 28%; PT <= 2 seconds of the IULN and PTT <= IULN; serum creatinine <= 1.5mg/dl or measured creatinine clearance >= 60 mL/min; 24 hour proteinuria <= 500mg/24 hours; total bilirubin < 2.0mg/dl; SGOT/SGPT <= 5 X IULN with liver mets or < 2.5 X IULN with no liver mets; no uncompensated coronary artery disease or history of previous thromboembolic events including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, uncontrolled atrial fibrillation, or hypertension; no evidence of severe vascular disease, diabetic or venous stasis ulcers or a history of deep venous or aterial thrombosis; no known HIV.
Publication Information Expand/Collapse
2016
Recommendations for clinical trial development in mantle cell lymphoma
PMid: PMID28040733 | PMC number: PMC n/a - Review
2009
A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-hodgkins lymphoma: Southwest Oncology Group study S0108 [PMID19373598; PMC3532923]
2005
Phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin's lymphoma (NHL): Southwest Oncology Group study S0108
2004
Expression of VEGF, VEGF receptors, and other angiogenic markers in relapsed aggressive non-Hodgkin's lymphoma: correlative studies from the SWOG S0108 trial
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Phase