SWOG clinical trial number
S0108

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

Closed
Phase
Accrual
87%
Published
Abbreviated Title
NON-HODGKIN'S: Bevacizumab For Relapsed Aggressive NHL
Activated
04/15/2001
Closed
12/01/2004
Participants
NCORP, Members, Medical Oncologists, Pathologists

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

S Spurgeon;B Till;P Martin;A Goy;M Dreyling;A Gopal;M Leblanc;JP Leonard;JW Friedberg;L Baizer;R Little;BS Kahl;MR Smith Journal of the National Cancer Institute, Dec 31;109(1). pii: djw263

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]

A Stopeck;J Unger;L Rimsza;W Bellamy;M Iannone;D Persky;M LeBlanc;R Fisher;T Miller Leukemia and Lymphoma 50(5):728-735

2005

Phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin's lymphoma (NHL): Southwest Oncology Group study S0108

AT Stopeck;W Bellamy;JM Unger;L Rimsza;M Iannone;RI Fisher;TP Miller Proc of the ASCO, JCO 23(16S):583s (#6592)

2004

Expression of VEGF, VEGF receptors, and other angiogenic markers in relapsed aggressive non-Hodgkin's lymphoma: correlative studies from the SWOG S0108 trial

A Stopeck;M Iannone;L Rimsza;T Miller;R Fisher;W Bellamy Blood 104(11): #2288