BATTLE Program: Umbrella Protocol for Patients With Non-Small Cell Lung Cancer (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00409968|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2006
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Lung Cancer||Procedure: Tumor Biopsy|
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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 drug(s) 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, and/or 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 and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or 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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||November 2006|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
Screening study to find out if Patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body are eligible to take part in 1 of 4 different research studies.
Procedure: Tumor Biopsy
A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).
- Biomarker Profile Assessment (before randomized allocation to research study) [ Time Frame: At enrollment ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409968
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vali Papadimitrakopoulou, MD||M.D. Anderson Cancer Center|