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LITT + Pembrolizumab for Glioblastoma
Study Summary
This trial will test the side effects and best dose of using LITT with Pembrolizumab to treat brain tumors.
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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Who is running the clinical trial?
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- My surgeon believes over 90% of my tumor can be treated with a specific heat therapy.I have an autoimmune disease treated with medication in the last 2 years.I have or had lung inflammation not caused by an infection.I have been diagnosed with HIV.My blood and organ function tests are within normal ranges.My kidney function is normal as tested within the last week.My liver is functioning well, as tested within the last week.I am currently being treated for an infection.I don't have any health issues that could affect the trial's results.My tumor cannot be fully treated with a specific laser technique due to its size.My diagnosis of glioblastoma or gliosarcoma is confirmed by a pathology report.I completed standard treatment with radiation and Temozolomide for my primary tumor.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have an active Hepatitis B or C infection.My doctor believes I won't need high doses of steroids.I have had 3 or fewer treatments for my recurrent brain cancer.I have taken a pregnancy test within the last 3 days and it was negative.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.I agree to use birth control during and for 4 months after the study.My tumor is 6.0 cm or smaller across.I have previously received immunotherapy, such as a vaccine or dendritic cell vaccine.I have another cancer that is getting worse or needs treatment.I have not had a live vaccine in the last 30 days.I have active brain metastases or cancer in the lining of my brain.My tumor is single and on one side, but it may have 1-2 stable secondary lesions.My tumor tissue sample is available for review.I can care for myself but may need occasional help.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.My tumor is located in the upper part of my brain.
- Group 1: Pembrolizumab injections 35 days after surgery
- Group 2: Pembrolizumab injections 14 days after surgery
- Group 3: Pembrolizumab injections 7 days before surgery
- 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
How many participants have thus far enrolled in this research endeavor?
"Currently, this research project is not accepting patients. It was initially posted on November 29th 2017 and its information was most recently updated on the 21st of November 2022. If you're looking for alternative studies, there are 442 clinical trials involving glioblastoma and 961 Laser Interstitial Thermotherapy experiences recruiting participants."
What is the primary goal of this clinical investigation?
"This clinical trial has a primary goal of determining the efficacy of timing LITT with pembrolizumab. Secondary objectives include assessing progression free survival at 12 and 24 months, as well as measuring overall PFS over up to two years for patients enrolled in the study."
Has Laser Interstitial Thermotherapy been studied in any other research initiatives?
"Currently, 961 medical studies regarding Laser Interstitial Thermotherapy are being conducted. Of those investigations, 122 have progressed to Phase 3 trials. The most common city for this research is Houston, Texas; however, a total of 35 731 locations across the world are running clinical tests related to the therapy's efficacy."
What diseases are most commonly treated with Laser Interstitial Thermotherapy?
"Laser Interstitial Thermotherapy is most commonly used to treat malignant neoplasms, but can also be used in instances of unresectable melanoma and microsatellite instability high. In some cases, it might even help with disease progression after chemotherapy."
Is this research effort currently searching for participants?
"Clinicaltrials.gov confirms that this trial is not presently accepting patients; it was first posted on the 29th of November 2017, with its most recent update occurring on the 21st of November 2022. Despite this particular study's inactive status, there are 1403 other clinical trials actively seeking patient enrolment at present."
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