Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113217
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2005-06-06
Brief Title:
Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMab VEGF Bevacizumab for Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The goal of this clinical research study is to learn if bevacizumab Avastin can control metastatic renal cell carcinoma RCC The safety of the treatment will also be studied
Objectives
Primary
1 To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression
2 Toxicities of therapy with bevacizumab in RCC
Secondary
Clinical
1 Response rate
2 Duration of response
3 Overall Survival
Preclinical
1 Serum and plasma levels of matrix metalloproteinase 9 MMP-9 and MMP-2 Interleukin 6 IL-6 vascular endothelial growth factor VEGF and Basic Fibroblast Growth Factor bFGF pre- and post- therapy optional studies
2 Tissue expression of Phospho-epidermal growth factor receptor EGFR VEGF vessel count CD3134 AKT and Phospho-AKT mitogen-activated protein kinase MAPK transforming growth factor-alpha TGF-alpha phospho-STAT3 and TUNEL post therapy optional studies
3 complementary DNA cDNA microarray analysis of tissue post-therapy optional studies
4 Tissue expression of tumor infiltrating lymphocytes and tumor antigens
5 Pathological response rate in primary tumor
6 To evaluate the Single Nucleotide Polymorphisms SNP patterns in nephrectomy specimens from patients participating in the study
Objectives
Primary
1 To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression
2 Toxicities of therapy with bevacizumab in RCC
Secondary
Clinical
1 Response rate
2 Duration of response
3 Overall Survival
Preclinical
1 Serum and plasma levels of matrix metalloproteinase 9 MMP-9 and MMP-2 Interleukin 6 IL-6 vascular endothelial growth factor VEGF and Basic Fibroblast Growth Factor bFGF pre- and post- therapy optional studies
2 Tissue expression of Phospho-epidermal growth factor receptor EGFR VEGF vessel count CD3134 AKT and Phospho-AKT mitogen-activated protein kinase MAPK transforming growth factor-alpha TGF-alpha phospho-STAT3 and TUNEL post therapy optional studies
3 complementary DNA cDNA microarray analysis of tissue post-therapy optional studies
4 Tissue expression of tumor infiltrating lymphocytes and tumor antigens
5 Pathological response rate in primary tumor
6 To evaluate the Single Nucleotide Polymorphisms SNP patterns in nephrectomy specimens from patients participating in the study
Detailed Description:
Bevacizumab is a drug that binds to and inhibits VEGF a blood-vessel stimulating agent with unusually high levels in kidney cancer This drug may decrease the growth of kidney cancer
Every two week study cycle you will receive a dose of bevacizumab intravenously through a needle in your vein The first bevacizumab dose will be given over 90 minutes as a continuous IV infusion If the first dose is tolerated without any side effects related to the intravenous IV infusion the second dose may be delivered over 60 minutes If the 60 minute infusion is tolerated all doses of bevacizumab after that may be given over 30 minutes If you experience infusion-related side effects with the 60 minute infusion all doses after that will be given over 90 minutes If you experience infusion-related side effects with the 30 minute infusion all doses after that will be given over 60 minutes Other drugs including Tylenol and Benadryl may be given before during and after the therapy to help prevent or ease side effects These drugs may be given either by mouth or through an IV line
During treatment blood samples about 1 12 tablespoons will be taken once per 2 week cycle Urine samples will be taken at the beginning of each cycle At around 56 days into treatment tumors will be measured using X-rays or other scans
Treatment will be stopped after 56 days of therapy In this first phase you will receive 4 doses of bevacizumab
If the cancer is stable or shrinks while on bevacizumab for the first 56 days and you tolerated the treatment well you will undergo surgery to remove your kidney tumor Surgery will be scheduled at least 4 weeks after your last dose of bevacizumab Approximately 4 weeks after surgery you will undergo repeat CT scans If your cancer is stable or continuing to shrink you will restart treatment with bevacizumab You will continue to have tumor measurements by scans around every 56 days 8 weeks while receiving bevacizumab if your initial scans showed evidence of tumor presence However If your tumor grew substantially during the operative period ie between the first set of scans on or around day 56 and the scans performed after surgery you will be taken off the study and other treatments will be offered to you
If the cancer grew while on bevacizumab for the first 56 days you will undergo surgery to remove your kidney tumor Surgery will be scheduled at least 4 weeks after your last dose of Bevacizumab After surgery you will not continue on bevacizumab Once you recover from surgery your doctor may recommend a different drug therapy to treat your cancer
In some circumstances after the first 56 days of therapy with bevacizumab your doctors may decide that it is not possible or helpful for your kidney to be removed because of progression of your cancer rendering such an operation either not feasible or inappropriate for your care In that case your doctors may recommend a different drug therapy for your cancer and you will not continue on bevacizumab
You may be taken off study if your disease progresses or intolerable side effects occur
If you are taken off study you will have repeat scans a physical examination blood testing about 2 tablespoons urine testing and an ECG If you have elevated blood pressure or excess protein in your urine you will be asked to come back every 2 months for repeat blood pressure testing and urine testing until these levels fall to a normal range for up to one year
This is an investigational study Avastin is commercially available and approved by the FDA for metastatic colorectal cancer and small cell lung cancer The drug is experimental and authorized for research purposes only in renal cell carcinoma Up to 50 participants will take part in this study All will be enrolled at The University of Texas UT MD Anderson Cancer Center
Every two week study cycle you will receive a dose of bevacizumab intravenously through a needle in your vein The first bevacizumab dose will be given over 90 minutes as a continuous IV infusion If the first dose is tolerated without any side effects related to the intravenous IV infusion the second dose may be delivered over 60 minutes If the 60 minute infusion is tolerated all doses of bevacizumab after that may be given over 30 minutes If you experience infusion-related side effects with the 60 minute infusion all doses after that will be given over 90 minutes If you experience infusion-related side effects with the 30 minute infusion all doses after that will be given over 60 minutes Other drugs including Tylenol and Benadryl may be given before during and after the therapy to help prevent or ease side effects These drugs may be given either by mouth or through an IV line
During treatment blood samples about 1 12 tablespoons will be taken once per 2 week cycle Urine samples will be taken at the beginning of each cycle At around 56 days into treatment tumors will be measured using X-rays or other scans
Treatment will be stopped after 56 days of therapy In this first phase you will receive 4 doses of bevacizumab
If the cancer is stable or shrinks while on bevacizumab for the first 56 days and you tolerated the treatment well you will undergo surgery to remove your kidney tumor Surgery will be scheduled at least 4 weeks after your last dose of bevacizumab Approximately 4 weeks after surgery you will undergo repeat CT scans If your cancer is stable or continuing to shrink you will restart treatment with bevacizumab You will continue to have tumor measurements by scans around every 56 days 8 weeks while receiving bevacizumab if your initial scans showed evidence of tumor presence However If your tumor grew substantially during the operative period ie between the first set of scans on or around day 56 and the scans performed after surgery you will be taken off the study and other treatments will be offered to you
If the cancer grew while on bevacizumab for the first 56 days you will undergo surgery to remove your kidney tumor Surgery will be scheduled at least 4 weeks after your last dose of Bevacizumab After surgery you will not continue on bevacizumab Once you recover from surgery your doctor may recommend a different drug therapy to treat your cancer
In some circumstances after the first 56 days of therapy with bevacizumab your doctors may decide that it is not possible or helpful for your kidney to be removed because of progression of your cancer rendering such an operation either not feasible or inappropriate for your care In that case your doctors may recommend a different drug therapy for your cancer and you will not continue on bevacizumab
You may be taken off study if your disease progresses or intolerable side effects occur
If you are taken off study you will have repeat scans a physical examination blood testing about 2 tablespoons urine testing and an ECG If you have elevated blood pressure or excess protein in your urine you will be asked to come back every 2 months for repeat blood pressure testing and urine testing until these levels fall to a normal range for up to one year
This is an investigational study Avastin is commercially available and approved by the FDA for metastatic colorectal cancer and small cell lung cancer The drug is experimental and authorized for research purposes only in renal cell carcinoma Up to 50 participants will take part in this study All will be enrolled at The University of Texas UT MD Anderson Cancer Center
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