Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513162
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2007-08-07
Brief Title:
Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Valproate Valproic Acid and Etoposide for Patients With Progressive Relapsed or Refractory Neuronal Tumors and Brain Metastases
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Primary Objective
Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide 50 mgm2day for children but only 25mgm2day for adults to start for four different age groups
Secondary Objectives
Determine the qualitative and quantitative toxicity and reversibility of toxicity of valproic acid in conjunction with oral etoposide
To investigate the clinical pharmacokinetics of valproic acid when given in conjunction with oral etoposide
To describe quality of life of patients with relapsed or progressive central and peripheral nervous system tumors when treated with oral valproic acid and etoposide
To observe and describe the response pattern of progressive central nervous system tumors treated with oral valproic acid and etoposide
To observe and describe event free survival time and overall survival time of patients with relapsed or progressive central nervous system tumors when treated with oral valproic acid and etoposide
To determine if histone deacetylase activity and topoisomerase expression in lymphocytes of patients is related to valproic acid levels and
To determine if the individual maximal tolerated dose iMTD depends on the initial performance status of the patient in the beginning of the treatment
Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide 50 mgm2day for children but only 25mgm2day for adults to start for four different age groups
Secondary Objectives
Determine the qualitative and quantitative toxicity and reversibility of toxicity of valproic acid in conjunction with oral etoposide
To investigate the clinical pharmacokinetics of valproic acid when given in conjunction with oral etoposide
To describe quality of life of patients with relapsed or progressive central and peripheral nervous system tumors when treated with oral valproic acid and etoposide
To observe and describe the response pattern of progressive central nervous system tumors treated with oral valproic acid and etoposide
To observe and describe event free survival time and overall survival time of patients with relapsed or progressive central nervous system tumors when treated with oral valproic acid and etoposide
To determine if histone deacetylase activity and topoisomerase expression in lymphocytes of patients is related to valproic acid levels and
To determine if the individual maximal tolerated dose iMTD depends on the initial performance status of the patient in the beginning of the treatment
Detailed Description:
Study Drugs
Etoposide is designed to block cell growth by breaking the DNA which may cause the cells to die
Valproic acid was first designed as an anti-seizure medication It was also found to change cancer cells and make them more sensitive to etoposide
Screening Tests
Before you start treatment on this study you will have screening tests These tests help your doctor decide if you are eligible to take part in this study
Your medical history will be reviewed
You will have a physical exam
You will be asked how well you are able to perform the normal activities of daily living performance status evaluation
You will complete a questionnaire about your activities or daily living The questionnaire will take about 5 to 10 minutes to complete
Blood about 2-3 tablespoons will be drawn for routine tests This routine blood draw may include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative
Urine may be collected to check for metabolic disease This urine sample may include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative
You will have a magnetic resonance imaging MRI or computed tomography CT scan
If your doctor thinks it is necessary you may have additional blood andor urine tests
Dose Escalation
When you begin the study you will begin receiving the lowest dose level of valproic acid Every week the dose will be increased This will continue until the maximum tolerated dose MTD is found Once the MTD is found you will continue to receive that dose level of valproic acid while you are on study However if your doctor thinks it is necessary this dose level could be lowered
If you are a child less than or equal to 18 years of age the amount of etoposide that you take while on study will not change
If you are an adult more than 18 years of age your will receive a low dose of etoposide while the MTD of valproic acid is being found After the MTD of valproic acid is found your dose of etoposide will be increased every week until the MTD is found However if your doctor thinks it is necessary this dose level could be lowered
Study Drug Administration
You will receive valproic acid and etoposide every evening in pill form
If you have difficulty swallowing the pills etoposide can be given in the evening in liquid form Valproic acid can be given in liquid form divided in 2 doses per day 1 in the morning and 1 in the evening
Study Visits During Dose Escalation
While your valproic acid or etoposide medication is being increased every week you will have a physical exam and blood about 2-3 tablespoonsand urine will be collected for routine tests
Every other month you will have CT or MRI scans to check the status of the disease You may have these tests and procedures more often if your doctor thinks it is necessary
Study Visits After Maximum Tolerated Dose MTD
Every month you will have a physical exam and blood about 2-3 tablespoons and urine will be collected for routine tests
Every other month you will have CT or MRI scans to check the status of the disease
Every 6 months a portion of the blood or urine collected for routine tests will be used for a pregnancy test for women who are able to have children
-You may have these tests and procedures more often if your doctor thinks it is necessary
Length of Study
You may remain on study for up to 2 years You will be taken off study if the disease gets worse or intolerable side effects occur
End-of-Study Visit
Once you are off study you will have an end-of-study visit At this visit the following tests and procedures will be performed
You will have a physical exam
Blood about 2-3 tablespoons and urine will be collected for routine tests
If your doctor thinks it is necessary you will have a CT or MRI to check the status of the disease
Follow-Up
Once you are off study you will be contacted by telephone once a year to check the status of the disease The phone call will take 2-3 minutes
This is an investigational study Etoposide is FDA approved and commercially available Valproic acid is FDA approved and commercially available for the treatment of seizures The use of these drugs together is investigational Up to 120 patients will take part in this multicenter study Up to 100 will be enrolled at M D Anderson
Etoposide is designed to block cell growth by breaking the DNA which may cause the cells to die
Valproic acid was first designed as an anti-seizure medication It was also found to change cancer cells and make them more sensitive to etoposide
Screening Tests
Before you start treatment on this study you will have screening tests These tests help your doctor decide if you are eligible to take part in this study
Your medical history will be reviewed
You will have a physical exam
You will be asked how well you are able to perform the normal activities of daily living performance status evaluation
You will complete a questionnaire about your activities or daily living The questionnaire will take about 5 to 10 minutes to complete
Blood about 2-3 tablespoons will be drawn for routine tests This routine blood draw may include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative
Urine may be collected to check for metabolic disease This urine sample may include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative
You will have a magnetic resonance imaging MRI or computed tomography CT scan
If your doctor thinks it is necessary you may have additional blood andor urine tests
Dose Escalation
When you begin the study you will begin receiving the lowest dose level of valproic acid Every week the dose will be increased This will continue until the maximum tolerated dose MTD is found Once the MTD is found you will continue to receive that dose level of valproic acid while you are on study However if your doctor thinks it is necessary this dose level could be lowered
If you are a child less than or equal to 18 years of age the amount of etoposide that you take while on study will not change
If you are an adult more than 18 years of age your will receive a low dose of etoposide while the MTD of valproic acid is being found After the MTD of valproic acid is found your dose of etoposide will be increased every week until the MTD is found However if your doctor thinks it is necessary this dose level could be lowered
Study Drug Administration
You will receive valproic acid and etoposide every evening in pill form
If you have difficulty swallowing the pills etoposide can be given in the evening in liquid form Valproic acid can be given in liquid form divided in 2 doses per day 1 in the morning and 1 in the evening
Study Visits During Dose Escalation
While your valproic acid or etoposide medication is being increased every week you will have a physical exam and blood about 2-3 tablespoonsand urine will be collected for routine tests
Every other month you will have CT or MRI scans to check the status of the disease You may have these tests and procedures more often if your doctor thinks it is necessary
Study Visits After Maximum Tolerated Dose MTD
Every month you will have a physical exam and blood about 2-3 tablespoons and urine will be collected for routine tests
Every other month you will have CT or MRI scans to check the status of the disease
Every 6 months a portion of the blood or urine collected for routine tests will be used for a pregnancy test for women who are able to have children
-You may have these tests and procedures more often if your doctor thinks it is necessary
Length of Study
You may remain on study for up to 2 years You will be taken off study if the disease gets worse or intolerable side effects occur
End-of-Study Visit
Once you are off study you will have an end-of-study visit At this visit the following tests and procedures will be performed
You will have a physical exam
Blood about 2-3 tablespoons and urine will be collected for routine tests
If your doctor thinks it is necessary you will have a CT or MRI to check the status of the disease
Follow-Up
Once you are off study you will be contacted by telephone once a year to check the status of the disease The phone call will take 2-3 minutes
This is an investigational study Etoposide is FDA approved and commercially available Valproic acid is FDA approved and commercially available for the treatment of seizures The use of these drugs together is investigational Up to 120 patients will take part in this multicenter study Up to 100 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