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Berzosertib + Radiation for Brain Metastases from Lung Cancer
Study Summary
This trial is testing the side effects and best dosage of a new drug, berzosertib, when given with whole brain radiation therapy, for patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread to the brain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 143 Patients • NCT01622868Trial Design
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Who is running the clinical trial?
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- I am allergic to medications similar to M6620.I do not have genetic conditions like Li Fraumeni syndrome or ataxia telangiectasia.I am not taking strong CYP3A4 inhibitors or inducers, and can change my epilepsy medication if needed.You are expected to live for more than two months so that you can finish the study treatment and be checked for any harmful effects.I have a significant brain shift or bleeding but am stable after seizure treatment.I have lung cancer with brain metastases and am considering palliative brain radiation.Your white blood cell count is at least 3,000 per microliter.I have 1-3 small brain tumors, can move around, and my doctor recommends whole brain radiation.I do not have any serious ongoing illnesses or situations that would stop me from following the study's requirements.I do not have HIV or I am not on HIV medication.I've had recent cancer treatment but am mostly recovered from serious side effects.I haven't had whole brain radiation therapy before, but treatments like SRS/SRT are okay if done 2 weeks before.I am not pregnant or breastfeeding.I am taking 8 mg or less of dexamethasone daily as I start WBRT.I can care for myself but may not be able to do active work, or I have significant neurological issues but am deemed fit for treatment.I agree to use birth control during and up to 6 months after the study.Women who can have children must have a negative pregnancy test.I am 18 years old or older.Your absolute neutrophil count is at least 1,500 per microliter of blood.I can provide tumor tissue from a surgery site other than the brain and will have fresh tissue from an upcoming brain surgery.My kidney function, measured by creatinine levels, is normal or nearly normal.My bilirubin levels are within the normal range for my condition.You need to have at least 100,000 platelets per microliter of blood.Your liver enzymes are within a certain range, unless you have liver metastases, in which case they can be slightly higher.
- Group 1: Group I (VX-970, whole-brain radiation therapy)
- Group 2: Group II (VX-970, surgery, whole-brain radiation therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruitment efforts still ongoing for this experiment?
"The trial is not currently open for recruitment and has not been updated since July 16th, 2022. Alternatively, 6683 trials related to carcinoma, small cell are actively enrolling participants while 15 investigations centred around Whole-Brain Radiotherapy remain available."
What hazards are associated with Whole-Brain Radiotherapy?
"Due to the limited existing data that supports its efficacy, Whole-Brain Radiotherapy has been given a score of 1 on our safety scale from 1 to 3."
Are there any documented precedents of Whole-Brain Radiotherapy trials?
"Whole-Brain Radiotherapy was initially studied at the National Institutes of Health Clinical Centre in 2015, with 156 trials having been completed since then. Currently, 15 clinical trials are actively recruiting participants across Saint Louis, Missouri."
What is the size of the cohort being monitored for this experiment?
"This research trial is no longer accepting new patients. It was initially posted on July 21st 2016 and the latest update occurred in July 16th 2022. If you are looking for other studies, 6683 trials recruiting participants with carcinoma small cell exist, as well as 15 investigations investigating Whole-Brain Radiotherapy that are still open to enrolment."
In which locations has this research been implemented?
"Nine clinical trial sites are currently recruiting patients for this study, including Washington University School of Medicine in Saint Louis, the University of Kentucky/Markey Cancer Center in Lexington and Mayo Clinic in Rochester. Additionally there is a further six locations offering participation opportunities."
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