Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma|
- Number of Participants With Response (Complete Response or Progressive Disease) [ Time Frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab), ] [ Designated as safety issue: No ]Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.
|Study Start Date:||March 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Avastin + Rituximab
Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
10 mg/kg given intravenously every 2 weeks for 4 doses.
Other Name: BevacizumabDrug: Rituximab
375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
Other Name: Rituxan
Hide Detailed Description
Bevacizumab is a new research drug that may help to stop or slow the growth of blood vessels in your tumor. These blood vessels are needed by the tumor to grow. Rituxan is a commercially available drug that is commonly used to treat relapsed and refractory lymphoma.
Before treatment starts, you will be asked questions about your medical history and about any surgeries you have had. You will have a complete physical exam including blood (around 3 tablespoons) and urine tests. You will have a sample of bone marrow collected to learn if the lymphoma has spread to the bone marrow. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have either a CT scan or a MRI of the neck, chest, abdomen, and pelvis, and you will have a gallium or PET scan. You will be asked about any medications that you are taking, including over-the-counter medications. Women who are able to have children must have a negative blood pregnancy test.
Additional blood samples (2 tablespoons) will be collected from you before starting therapy and every 2 months during this study for tests to help your doctors and researchers to learn more about how Bevacizumab works.
During the study, you will be given a dose of rituximab by vein once a week for 8 weeks in a row, and a dose of Bevacizumab every other week. The drugs will be contained in a bag and will be given to you through a needle in one of your veins. This method of giving the drugs is called an infusion. The infusion of Bevacizumab may take 1 to 2 hours, and the infusion of rituximab may take up to 3 to 6 hours. This method of giving a drug is called an infusion. In the first week, infusions of rituxan and Bevacizumab will be given on the same day.
During the infusion of each drug, you will have your vital signs checked often and you will be watched for any side effects. If you experience side effects, the infusion may be slowed down or stopped until the symptoms have gone away.
Within 2 weeks after your 8th dose of rituximab, (4th dose of Bevacizumab) you will have a follow-up visit scheduled to evaluate the status of the disease. During the follow-up visit, you will have a physical exam and blood (around 4 tablespoons) will be collected for lab tests. You will have a CT scan or a MRI, gallium or PET scan, and bone marrow biopsy (if needed). If the disease gets worse or you experience any intolerable side effects, you will be taken off the study. If you are taken off the study or your doctor decides that you should stop study treatment, you will be asked to return to M. D. Anderson for all of the scheduled follow-up visits to check for long term side effects of the drug and to check on the status of the disease.
If the disease remains stable or shrinks after 8 weeks of therapy, you may continue to receive Bevacizumab treatments every 2 weeks for a maximum of a total of 6 months. Even if the treatment is shown to be of benefit to you, your doctor may not continue to give you additional treatments with Bevacizumab beyond the total of 6 months.
After treatment, you will have follow-up visits scheduled to check on the status of the disease. These visits will be scheduled every 3 months for 1 year, then every 4 months for 1 more year, then every 6 months until the disease gets worse. During these visits, you will have a physical exam, blood tests (around 2 tablespoons), and either a CT scan or a MRI. You will also have a sample of bone marrow collected.
This is an investigational study. Bevacizumab has been authorized by the FDA for use in research only. Rituximab is FDA approved and is commercially available. There will be no cost for Bevacizumab or for any tests and procedures that are not considered part of standard of care. Up to 40 patients will take part in this study. All patients will be enrolled at M. D. Anderson.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Barbara Pro, MD||M.D. Anderson Cancer Center|