S0108 Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Anaplastic Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

In brief

Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for non-Hodgkin's lymphoma

Key facts

Study ID

NCT00016094

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2001-04-01

Expected to finish

2008-09-01

Last updated by the study team

2013-01-29

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have biopsy proven relapsed (first or second relapse) non-Hodgkin's lymphoma, aggressive histology of one of the following histologic subtypes; transformed non-Hodgkin's lymphoma patients are not eligible for this study:
• Diffuse large (formerly Working Formulation Groups F, G, H)
• High-grade, Burkitt's or Burkitt-like
• Primary mediastinal
• Anaplastic large cell
• Mantle cell
• Note: patients being registered to this study at first relapse must not be suitable for transplant or aggressive treatment at first relapse
• Patients must have measurable disease; all techniques used to measure disease must be completed within 28 days prior to registration and must have been done after completion of prior therapy
• Patients must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis within 28 days prior to registration and they must have been done after completion of prior chemotherapy
• Patients must have either a unilateral or bilateral bone marrow aspirate and biopsy within 42 days prior to registration
• Patients must have had 1 or 2 prior chemotherapy regimens (pre-induction and autologous bone marrow transplantation will be considered as one prior therapy) for lymphoma; this includes investigational agents and/or other antibody therapies; all prior therapy must have been completed at least 2 weeks prior to registration; due to possible interactions with the rituximab antibody; patients previously receiving rituximab must have completed rituximab therapy at least 12 weeks prior to registration; if rituximab is given as a single agent after a relapse, it is considered a separate regimen and will be counted as such; if the rituximab is given in combination for either the first or second relapse or as consolidation after chemotherapy regimen without an intervening relapse, it will be considered part of the combination regimen and counted as one prior therapy; patients must have recovered from any chemotherapy-related toxicities prior to registration
• Patient must not have undergone major surgery within 4 weeks prior to registration (this does not apply to placement of venous access device) or received any radiotherapy within 2 weeks prior to registration
• Patients must not be receiving or planning to receive oral steroids for any condition at the time of registration; use of a steroid inhaler or nasal spray is allowed
• Patients must not require 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
• Patients must not have any acute healing bone fracture
• Patients must not have a history of uncontrolled seizures
• A pretreatment sample of plasma whole blood, bone marrow (if there is bone marrow involvement with lymphoma) urine and unstained diagnostic paraffin slides must be submitted for correlative studies)
• All patients must have a performance status of 0, 1 or 2 according to Zubrod criteria
• Patients must not have central nervous system involvement with lymphoma
• ANC >= 500
• Platelets >= 75,000
• Hematocrit >= 28%
• Prothrombin time (PT) =< 2 seconds of the institutional upper limit of normal (IULN) and partial prothrombin time (PTT) =< IULN within 14 days prior to registration
• Serum creatinine =< 1.5 mg/dl or measured creatinine clearance >= 60 mL/min
• Patients must have a 24 hour proteinuria =< 500mg/24hours

Where it is running

• Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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