Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509782
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-30
Brief Title:
Phase I Trial of ZIO-101 in Patients With Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Trial of ZIO-101 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-07
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 Objectives
1 To determine the toxicities and maximum tolerated dose MTD of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors
2 To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks
Secondary Objective
1 To determine the anti-tumor effects of ZIO-101
1 To determine the toxicities and maximum tolerated dose MTD of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors
2 To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks
Secondary Objective
1 To determine the anti-tumor effects of ZIO-101
Detailed Description:
ZIO-101 is a drug that may change cancerous cells into healthy benign cells It is also designed to cause cancer cells to destroy themselves a term called apoptosis
Before you can start treatment on this study you will have what are called screening tests no more than one week before starting the study These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam including measurements of your weight blood pressure pulse and temperature You will also be asked what other medicines you are taking and about your general well-being You will have an electrocardiogram ECG - a test to measure the electrical activity of the heart Blood about 2 12 tablespoons will be drawn A sample of urine will be also be collected and tested to see if your kidneys are working correctly Women who are able to have children must have a negative urine pregnancy test
To see the current condition of your tumor additional tests may need to be performed if they have not already been done recently These tests may include a chest x-ray a CT scan imaging computer pictures of your body a bone scan an imaging test of your bones with a contrast material or an MRI a detailed imaging scan of certain areas of your body
If you are found to be eligible to take part in this study you will begin treatment with ZIO-101 Immediately before being treated with ZIO-101 on Day 0 you will have another physical exam and you will be asked about any medicines you are taking and how you are feeling You will also be asked a series of questions which will assess your mental health This is called a mini-mental status exam and will take approximately 10 minutes to complete The blood tests may need to be repeated along with the ECG and the urine test In addition a small blood sample about 10 teaspoons must be taken immediately before the injection of ZIO-101 This blood will be used to help in the measurement of drug levels in the blood These are called pharmacokinetic PK tests This blood sample will also be used to measure arsenic levels in your blood
ZIO-101 will be injected into your vein over 60 minutes in the clinical translational research center of UTMDACC This drug must be given through a special IV called a central line catheter so that it does not damage your surrounding tissue You will have to sign a separate consent document before placement of a catheter can be performed Special care will be taken to be sure the drug does not leak into surrounding tissue The use of anti-nausea and other supportive care medications may be given during the infusion
Following the injection you will have 6 samples of blood taken for PK tests at half an hour and 1 2 4 8 and 12 hours after finishing the treatment
For the next 4 days at about the same time as your first infusion you will be prepared for treatment with ZIO-101 Before each injection you will be asked how you feel an ECG will be performed and a small sample of blood about 2 teaspoons will be drawn for PK tests The Day 1-4 infusions will also each take about 1 hour In total you will receive 5 daily injections of ZIO-101 On Day 4 at the end of the infusion another sample of blood will be drawn about 5 teaspoons to measure arsenic levels in your blood
Your next visit will be Week 2 and at the start of this visit a blood sample about 2 teaspoons will be drawn for PK tests and you will be asked how you feel At Week 3 another blood sample about 7 teaspoons will be drawn for PK tests and to measure arsenic levels in your blood and you will again be asked how you feel
At Week 4 a new cycle begins Immediately before being treated with ZIO-101 you will have a physical examination and you will take a mini-mental status examination you will be asked about any medicines you are taking and how you are feeling The blood tests will be repeated along with the ECG and the routine urine test In addition tests to measure your tumor will be repeated
This study is trying to find the best dose of ZIO-101 At first 3 patients will be assigned to the first dose level They will be followed to evaluate their side effects for a period of 4 weeks before 3 more patients are enrolled If none of the patients develop serious side effects the dose escalation will continue If 1 of the 3 patients in a particular dose level develops significant side effects 3 more patients will be enrolled at that level If 2 or more of the 6 patients develop serious side effects then the escalation will finish and all future patients on this study will be treated at a lower dose level half way between this level and the previous one
You may receive up to 6 cycles of treatment You may be taken off study early if your disease gets worse or intolerable side effects occur Once you go off study you will have an end of study visit During this visit you will have a physical exam a mini-mental status exam and blood about 3 teaspoons will be drawn for routine tests
This is an investigational study ZIO-101 has been authorized by the FDA for use in research only ZIO-101 will be provided free of charge during the study Also any tests or procedures that are being done solely for the purpose of this research study will be provided free of charge Up to 50 patients will take part in this multicenter study All will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests no more than one week before starting the study These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam including measurements of your weight blood pressure pulse and temperature You will also be asked what other medicines you are taking and about your general well-being You will have an electrocardiogram ECG - a test to measure the electrical activity of the heart Blood about 2 12 tablespoons will be drawn A sample of urine will be also be collected and tested to see if your kidneys are working correctly Women who are able to have children must have a negative urine pregnancy test
To see the current condition of your tumor additional tests may need to be performed if they have not already been done recently These tests may include a chest x-ray a CT scan imaging computer pictures of your body a bone scan an imaging test of your bones with a contrast material or an MRI a detailed imaging scan of certain areas of your body
If you are found to be eligible to take part in this study you will begin treatment with ZIO-101 Immediately before being treated with ZIO-101 on Day 0 you will have another physical exam and you will be asked about any medicines you are taking and how you are feeling You will also be asked a series of questions which will assess your mental health This is called a mini-mental status exam and will take approximately 10 minutes to complete The blood tests may need to be repeated along with the ECG and the urine test In addition a small blood sample about 10 teaspoons must be taken immediately before the injection of ZIO-101 This blood will be used to help in the measurement of drug levels in the blood These are called pharmacokinetic PK tests This blood sample will also be used to measure arsenic levels in your blood
ZIO-101 will be injected into your vein over 60 minutes in the clinical translational research center of UTMDACC This drug must be given through a special IV called a central line catheter so that it does not damage your surrounding tissue You will have to sign a separate consent document before placement of a catheter can be performed Special care will be taken to be sure the drug does not leak into surrounding tissue The use of anti-nausea and other supportive care medications may be given during the infusion
Following the injection you will have 6 samples of blood taken for PK tests at half an hour and 1 2 4 8 and 12 hours after finishing the treatment
For the next 4 days at about the same time as your first infusion you will be prepared for treatment with ZIO-101 Before each injection you will be asked how you feel an ECG will be performed and a small sample of blood about 2 teaspoons will be drawn for PK tests The Day 1-4 infusions will also each take about 1 hour In total you will receive 5 daily injections of ZIO-101 On Day 4 at the end of the infusion another sample of blood will be drawn about 5 teaspoons to measure arsenic levels in your blood
Your next visit will be Week 2 and at the start of this visit a blood sample about 2 teaspoons will be drawn for PK tests and you will be asked how you feel At Week 3 another blood sample about 7 teaspoons will be drawn for PK tests and to measure arsenic levels in your blood and you will again be asked how you feel
At Week 4 a new cycle begins Immediately before being treated with ZIO-101 you will have a physical examination and you will take a mini-mental status examination you will be asked about any medicines you are taking and how you are feeling The blood tests will be repeated along with the ECG and the routine urine test In addition tests to measure your tumor will be repeated
This study is trying to find the best dose of ZIO-101 At first 3 patients will be assigned to the first dose level They will be followed to evaluate their side effects for a period of 4 weeks before 3 more patients are enrolled If none of the patients develop serious side effects the dose escalation will continue If 1 of the 3 patients in a particular dose level develops significant side effects 3 more patients will be enrolled at that level If 2 or more of the 6 patients develop serious side effects then the escalation will finish and all future patients on this study will be treated at a lower dose level half way between this level and the previous one
You may receive up to 6 cycles of treatment You may be taken off study early if your disease gets worse or intolerable side effects occur Once you go off study you will have an end of study visit During this visit you will have a physical exam a mini-mental status exam and blood about 3 teaspoons will be drawn for routine tests
This is an investigational study ZIO-101 has been authorized by the FDA for use in research only ZIO-101 will be provided free of charge during the study Also any tests or procedures that are being done solely for the purpose of this research study will be provided free of charge Up to 50 patients will take part in this multicenter 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