Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512460
Status:
TERMINATED
Last Update Posted:
2016-05-16
First Post:
2007-08-03
Brief Title:
RTA 744 Injection in Patients With Leptomeningeal Disease
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent Progressive or Refractory Neoplastic Meningitis
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed due to loss of industry sponsorship
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 The primary objectives of this study are
1 To determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease LMD secondary to any type of primary tumor
2 In a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose MTD to characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF
2 The secondary objectives of this study are
1 To document any potential antitumor activity of RTA 744 in this patient population
2 To correlate pharmacokinetic information with clinical efficacy and safety responses as a possible help in selecting appropriate doses for later studies
1 To determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease LMD secondary to any type of primary tumor
2 In a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose MTD to characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF
2 The secondary objectives of this study are
1 To document any potential antitumor activity of RTA 744 in this patient population
2 To correlate pharmacokinetic information with clinical efficacy and safety responses as a possible help in selecting appropriate doses for later studies
Detailed Description:
RTA 744 is designed to enter the spinal fluid and kill cancer cells both in the spinal fluid and in the rest of body
Before you can start receiving the study drug you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded You will be asked about any drugs you have taken and are taking You will have a physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate You will have a neurological exam Blood about 2 tablespoons will be drawn for routine tests This routine blood draw will 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 will be collected over a 24-hour period to test kidney function and for routine tests You will have a magnetic resonance imaging MRI scan of the brain and spine
You will have a chest x-ray You will be asked questions about your ability to perform daily activities performance status evaluation You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart You will have either a multiple gated acquisition scan MUGA or an echocardiogram to check your hearts health Samples 1 12 teaspoons of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells The spinal sample will be collected through a lumbar puncture spinal tap The other sample will be taken from your brain through an Ommaya Reservoir tap Radioactive dye will be injected into the CSF to make sure the CSF flows freely throughout the spinal canal This is called an Indium-111 DPTA or Technetium 99m-DPTA Flow Study
If you are found to be eligible to take part in this study you should receive the same dose of RTA 744 throughout the study The amount of study drug you receive will be determined by when you begin the study Every 21 days on study is considered 1 study cycle If you have intolerable side effects the drug dosing for the next cycle may be delayed for up to 21 days to allow any symptoms or side effects to resolve You may be given a lower dose level
The first participant on this study will receive the dose that has been found to be well-tolerated in an ongoing study involving participants with primary brain tumors After this participant has completed 1 study cycle the next participant will be given a higher dose of RTA 744 Each new participant will receive a higher dose level until a patient has an intolerable side effect When this happens at least 2 more participants will be given the dose level that causes the intolerable side effect If there are no further intolerable side effects to RTA 744 the next group of 3 participants will be given the next higher dose of RTA 744 Each time the dose of RTA 744 will not be increased until the effects of the previous dose level have been studied Doses will increase with each group of patients until the highest tolerable dose is found
On Day 1 Cycle 1 before you receive the first dose of RTA 744 you will have a physical exam neurological exam and a performance status evaluation If the screening neurological exam was performed less than 1 week before Day 1 the neurological exam will not need to be repeated You will also be asked about any drugs treatments or herbal medicines you are taking You will be asked how you are feeling and if whether you are experiencing any symptoms or side effects Blood less than 2 tablespoons and urine will be collected for routine tests unless blood and urine were collected for screening within the past 72 hours
After completion of these tests you will receive RTA 744 through a needle in your vein over a 2-hour period on Days 1-3 You must remain in the clinic for 2 hours after the drug is given to make sure you are not having any side effects
During Cycle 1 you will be asked to return to the clinic once a week for 3 weeks At these visits blood less than 2 tablespoons will be drawn for routine tests You will be asked how you are feeling and whether you are having any side effects
On Day 21 you will have a neurologic exam
Before receiving the study drug on Day 1 of Cycles 2-18 you will have a physical exam neurological exam and a performance status evaluation You will also be asked about any drugs treatments or herbal medicines you are taking Blood less than 2 tablespoons and urine will be collected for routine tests You will have an ECG Before Cycles 4 6 8 10 12 1416 and 18 you will have a MUGA scan or an echocardiogram Once you have completed the tests you will receive the study drug in the same manner as Cycle 1
During Days 1-3 you will be asked how you are feeling and to report any symptoms or side effects you may have noticed during or after receiving RTA 744
On Day 15 blood about 3 teaspoons will be drawn for routine tests This blood draw may be performed by an outside laboratory If no clinic visit is scheduled on Day 15 you will be contacted by telephone to find out if you have experienced any side effects This phone call should last less than 5 minutes
On Day 21 blood less than 2 tablespoons will be drawn for routine tests
One time per cycle between Day 15 and Day 21 of Cycles 2 4 6 8 10 12 14 16 and 18 a sample about 2 teaspoon each time of CSF will be collected from your spine through a spinal tap and from your brain through an Ommaya Reservoir tap This will be done in order to look for cancer cells You will also have an MRI of the brain and spine
An ECG will be performed during the last week of all cycles A MUGA scan or an echocardiogram will be performed during the last week of Cycles 4 6 8 10 12 14 16 and 18
You will have an MRI within 1 week of the end of the last cycle
You may remain on study for up to 18 cycles 13 months You will be taken off study if the disease gets worse or intolerable side effects occur
Once you are off study you will have an end-of-study visit At this visit your complete medical history will be recorded You will be asked about any drugs you have taken and are taking You will have a physical exam including measurement of vital signs You will have a neurological exam Blood about 2 tablespoons will be drawn for routine tests Urine will be collected over a 24-hour period to test kidney function and for routine tests You will have an MRI of the brain and spine
You will have a chest x-ray You will have a performance status evaluation You will have ECG and MUGA scans or echocardiogram Samples 1 12 teaspoons each of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells The spinal sample will be collected through a spinal tap The other sample will be taken from your brain through an Ommaya Reservoir tap Radioactive dye will also be injected into the CSF to make sure the CSF flows freely throughout the spinal canal
THIS IS AN INVESTIGATIONAL STUDY RTA 744 is not FDA approved or commercially available It has been authorized for use in research only
Up to 18 patients will take part in this study All will be enrolled at M D Anderson
Before you can start receiving the study drug you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded You will be asked about any drugs you have taken and are taking You will have a physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate You will have a neurological exam Blood about 2 tablespoons will be drawn for routine tests This routine blood draw will 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 will be collected over a 24-hour period to test kidney function and for routine tests You will have a magnetic resonance imaging MRI scan of the brain and spine
You will have a chest x-ray You will be asked questions about your ability to perform daily activities performance status evaluation You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart You will have either a multiple gated acquisition scan MUGA or an echocardiogram to check your hearts health Samples 1 12 teaspoons of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells The spinal sample will be collected through a lumbar puncture spinal tap The other sample will be taken from your brain through an Ommaya Reservoir tap Radioactive dye will be injected into the CSF to make sure the CSF flows freely throughout the spinal canal This is called an Indium-111 DPTA or Technetium 99m-DPTA Flow Study
If you are found to be eligible to take part in this study you should receive the same dose of RTA 744 throughout the study The amount of study drug you receive will be determined by when you begin the study Every 21 days on study is considered 1 study cycle If you have intolerable side effects the drug dosing for the next cycle may be delayed for up to 21 days to allow any symptoms or side effects to resolve You may be given a lower dose level
The first participant on this study will receive the dose that has been found to be well-tolerated in an ongoing study involving participants with primary brain tumors After this participant has completed 1 study cycle the next participant will be given a higher dose of RTA 744 Each new participant will receive a higher dose level until a patient has an intolerable side effect When this happens at least 2 more participants will be given the dose level that causes the intolerable side effect If there are no further intolerable side effects to RTA 744 the next group of 3 participants will be given the next higher dose of RTA 744 Each time the dose of RTA 744 will not be increased until the effects of the previous dose level have been studied Doses will increase with each group of patients until the highest tolerable dose is found
On Day 1 Cycle 1 before you receive the first dose of RTA 744 you will have a physical exam neurological exam and a performance status evaluation If the screening neurological exam was performed less than 1 week before Day 1 the neurological exam will not need to be repeated You will also be asked about any drugs treatments or herbal medicines you are taking You will be asked how you are feeling and if whether you are experiencing any symptoms or side effects Blood less than 2 tablespoons and urine will be collected for routine tests unless blood and urine were collected for screening within the past 72 hours
After completion of these tests you will receive RTA 744 through a needle in your vein over a 2-hour period on Days 1-3 You must remain in the clinic for 2 hours after the drug is given to make sure you are not having any side effects
During Cycle 1 you will be asked to return to the clinic once a week for 3 weeks At these visits blood less than 2 tablespoons will be drawn for routine tests You will be asked how you are feeling and whether you are having any side effects
On Day 21 you will have a neurologic exam
Before receiving the study drug on Day 1 of Cycles 2-18 you will have a physical exam neurological exam and a performance status evaluation You will also be asked about any drugs treatments or herbal medicines you are taking Blood less than 2 tablespoons and urine will be collected for routine tests You will have an ECG Before Cycles 4 6 8 10 12 1416 and 18 you will have a MUGA scan or an echocardiogram Once you have completed the tests you will receive the study drug in the same manner as Cycle 1
During Days 1-3 you will be asked how you are feeling and to report any symptoms or side effects you may have noticed during or after receiving RTA 744
On Day 15 blood about 3 teaspoons will be drawn for routine tests This blood draw may be performed by an outside laboratory If no clinic visit is scheduled on Day 15 you will be contacted by telephone to find out if you have experienced any side effects This phone call should last less than 5 minutes
On Day 21 blood less than 2 tablespoons will be drawn for routine tests
One time per cycle between Day 15 and Day 21 of Cycles 2 4 6 8 10 12 14 16 and 18 a sample about 2 teaspoon each time of CSF will be collected from your spine through a spinal tap and from your brain through an Ommaya Reservoir tap This will be done in order to look for cancer cells You will also have an MRI of the brain and spine
An ECG will be performed during the last week of all cycles A MUGA scan or an echocardiogram will be performed during the last week of Cycles 4 6 8 10 12 14 16 and 18
You will have an MRI within 1 week of the end of the last cycle
You may remain on study for up to 18 cycles 13 months You will be taken off study if the disease gets worse or intolerable side effects occur
Once you are off study you will have an end-of-study visit At this visit your complete medical history will be recorded You will be asked about any drugs you have taken and are taking You will have a physical exam including measurement of vital signs You will have a neurological exam Blood about 2 tablespoons will be drawn for routine tests Urine will be collected over a 24-hour period to test kidney function and for routine tests You will have an MRI of the brain and spine
You will have a chest x-ray You will have a performance status evaluation You will have ECG and MUGA scans or echocardiogram Samples 1 12 teaspoons each of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells The spinal sample will be collected through a spinal tap The other sample will be taken from your brain through an Ommaya Reservoir tap Radioactive dye will also be injected into the CSF to make sure the CSF flows freely throughout the spinal canal
THIS IS AN INVESTIGATIONAL STUDY RTA 744 is not FDA approved or commercially available It has been authorized for use in research only
Up to 18 patients will take part in this study All 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