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Lapatinib + Temozolomide + Radiation for Glioblastoma
Study Summary
This trial is for patients with newly diagnosed glioblastoma multiforme. The standard treatment for this cancer is radiation therapy and the chemotherapy agent Temozolomide. However, the study drug Lapatinib has not been FDA approved for use in brain tumor treatment. This study is testing to see if Lapatinib is safe and effective when given in combination with radiation therapy and Temozolomide.
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.Trial Design
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- I do not have any serious illnesses or infections that are not under control.I do not have active liver or bile duct disease, except as allowed by my doctor.My condition does not hide side effects or change how drugs work in my body.I have a confirmed diagnosis of GBM or GS, possibly upgraded from a lower grade after surgery.I can provide 20-30 slides or at least 200mg of frozen tissue samples.I have had radiation therapy to my brain.I have had treatments targeting my brain tumor.I have been cancer-free from another type for at least 3 years.I started brain radiation and chemotherapy 2-5 weeks after my surgery.I am over 18 years old and expected to live more than 12 weeks.I can care for myself but may not be able to do active work.My recent tests show my bone marrow, liver, and kidneys are functioning well.I am not pregnant, breastfeeding, and I use effective birth control.I agree not to take other cancer drugs during my lapatinib, temozolomide, and radiation treatment.I've had a brain scan within the last 3 weeks, preferably an MRI.I haven't taken certain prohibited medications or EIAEDs in the last 2 weeks.
- Group 1: Lapatinib/Temozolomide/radiation
- 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
To what extent are Lapatinib, Temozolomide and radiation therapy safe for individuals receiving treatment?
"Lapatinib/Temozolomide/radiation has been given a safety score of 2, as there are some clinical data to support its security but no evidence yet verifying its effectiveness."
Are there any available slots left for individuals to participate in this research?
"According to clinicaltrials.gov, this research project is not presently accepting participants; the initial listing was posted on December 7th 2012 and last updated September 9th 2022. Nonetheless, there are currently 441 other trials seeking volunteers."
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What portion of applicants met pre-screening criteria?
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