Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409968
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2006-12-08
Brief Title:
BATTLE Program Umbrella Protocol for Patients With Non-Small Cell Lung Cancer NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This trial is referred to as the umbrella trial The BATTLE program consists of this umbrella trial plus four phase II protocols into which the umbrella patients are enrolled Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker analysis that will be used to assign them to one of the four phase II studies All patients enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol
Detailed Description:
This study is the umbrella or screening study in a group of 5 studies known as the BATTLE Biomarker-integrated Approaches of Targeted Therapy of Lung Cancer Elimination program In order to participate in one of the research studies you must first agree to take part in this screening study which will be used to determine if you are eligible After participating in this study you may be assigned to a study that is using an investigational drug The investigational drugs to be used in each of the 4 studies are not approved by the Food and Drug Administration FDA for commercial use in this setting however the FDA has permitted its use in these research studies
If you agree to participate in this screening study your complete medical history including smoking history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature and breathing rate height and weight You will have blood about 2 teaspoons drawn for routine tests You will also have blood about 1-2 tablespoons drawn to check your blood clotting function thyroid function and lipid fat levels You will have a urine test a performance status evaluation questions about your ability to perform everyday activities and an electrocardiogram ECG -- a test that measures the electrical activity of the heart
Your tumor will be evaluated by chest x-ray and computed tomography CT or magnetic resonance imaging MRI scans to evaluate the status of the disease You will have a brain MRI Women who are able to have children must have a negative blood about 1 teaspoon pregnancy test before receiving the study drug
A sample of your tumor tissue will be collected for biomarker analysis If your tumor tissue cannot be reached you will not be able to participate in this research study To collect a tumor biopsy you will have either a CT-guided core biopsy bronchoscopy or other type of biopsy such as subcutaneous cutaneous or lymph node You will be asked to stop taking any medication that affects blood-clotting such as aspirin or coumadin before the biopsy procedure
For the cutaneous skin biopsy you will be given a local anesthetic by either a spray or shot to numb your skin A small cut will be made to remove all or a piece of the affected skin
For the CT-guided core biopsy of the lung subcutaneous andor lymph node biopsy a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe The needle is guided while being viewed by the physician on a CT scan Any site that can be safely biopsied will be considered for the collection of tissue Sites not commonly biopsied include kidneys adrenal glands and brain
For the bronchoscopy you will be given drugs to relax and then a local anesthetic will be sprayed into your nose and throat to numb those areas A slim flexible tube with a light will be placed through your nose or mouth and into your lungs A small brush will be fed through the tube and into your lungs The brush will gently scrape off a sample of lung tissue Tweezers will then be fed through the tube to collect the tissue samples biopsy A small amount of water will be sprayed into your lungs and then suctioned out through the tube to collect tissue samples and mucous samples
For the CT-guided core biopsy or bronchoscopy you should not take any medications by mouth or have any solid food for at least 6 hours before the procedure You also should not have any liquids 2 hours before the procedure
If you are eligible to take part in this study you will be assigned to 1 of the 4 research studies based on the results of your tumor analysis You will be asked to read and sign a separate informed consent to take part in one of the research studies
You have the right to leave the study at any time If you choose to stop participating in this study you should contact the study chair andor research nurse Your doctor may decide to take you off this study if your medical condition gets worse andor you are unable to comply with study requirements
This is an investigational study Up to 250 patients will take part in this study All will be enrolled at M D Anderson
If you agree to participate in this screening study your complete medical history including smoking history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature and breathing rate height and weight You will have blood about 2 teaspoons drawn for routine tests You will also have blood about 1-2 tablespoons drawn to check your blood clotting function thyroid function and lipid fat levels You will have a urine test a performance status evaluation questions about your ability to perform everyday activities and an electrocardiogram ECG -- a test that measures the electrical activity of the heart
Your tumor will be evaluated by chest x-ray and computed tomography CT or magnetic resonance imaging MRI scans to evaluate the status of the disease You will have a brain MRI Women who are able to have children must have a negative blood about 1 teaspoon pregnancy test before receiving the study drug
A sample of your tumor tissue will be collected for biomarker analysis If your tumor tissue cannot be reached you will not be able to participate in this research study To collect a tumor biopsy you will have either a CT-guided core biopsy bronchoscopy or other type of biopsy such as subcutaneous cutaneous or lymph node You will be asked to stop taking any medication that affects blood-clotting such as aspirin or coumadin before the biopsy procedure
For the cutaneous skin biopsy you will be given a local anesthetic by either a spray or shot to numb your skin A small cut will be made to remove all or a piece of the affected skin
For the CT-guided core biopsy of the lung subcutaneous andor lymph node biopsy a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe The needle is guided while being viewed by the physician on a CT scan Any site that can be safely biopsied will be considered for the collection of tissue Sites not commonly biopsied include kidneys adrenal glands and brain
For the bronchoscopy you will be given drugs to relax and then a local anesthetic will be sprayed into your nose and throat to numb those areas A slim flexible tube with a light will be placed through your nose or mouth and into your lungs A small brush will be fed through the tube and into your lungs The brush will gently scrape off a sample of lung tissue Tweezers will then be fed through the tube to collect the tissue samples biopsy A small amount of water will be sprayed into your lungs and then suctioned out through the tube to collect tissue samples and mucous samples
For the CT-guided core biopsy or bronchoscopy you should not take any medications by mouth or have any solid food for at least 6 hours before the procedure You also should not have any liquids 2 hours before the procedure
If you are eligible to take part in this study you will be assigned to 1 of the 4 research studies based on the results of your tumor analysis You will be asked to read and sign a separate informed consent to take part in one of the research studies
You have the right to leave the study at any time If you choose to stop participating in this study you should contact the study chair andor research nurse Your doctor may decide to take you off this study if your medical condition gets worse andor you are unable to comply with study requirements
This is an investigational study Up to 250 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-01767 | REGISTRY | CTRP ID | None |
| W81XWH-06-1-0303 | OTHER | None | None |