Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081861
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2004-04-23
Brief Title:
Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkins Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
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a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle You will have either a CT scan or a MRI of the neck chest abdomen and pelvis and you will have a gallium or PET scan You will be asked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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None