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LITT + Pembrolizumab for Glioblastoma
Phase 1 & 2
Recruiting
Led By Andrew Sloan, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate Organ Function Laboratory Values: ANC ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥9.0 g/gL, Creatine ≤1.7 x upper limit of normal, Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN, INR or PT ≤ 1.5 x ULN, aPTT ≤ 1.5 x ULN
Histopathologically proven diagnosis of glioblastoma or gliosarcoma prior to registration by pathology report
Must not have
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has known history of, or any evidence of active, non-infectious pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after diagnosis
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the side effects and best dose of using LITT with Pembrolizumab to treat brain tumors.
Who is the study for?
This trial is for adults with confirmed glioblastoma or gliosarcoma who've completed standard chemoradiation. They must have good organ function, a Karnofsky performance status of ≥60, and be able to consent. Women of childbearing potential must test negative for pregnancy and agree to contraception. The tumor should be treatable with LITT, unifocal & unilateral, and not exceed 6 cm in diameter.
What is being tested?
The study tests the effectiveness and side effects of combining Laser Interstitial Thermotherapy (LITT), a minimally invasive surgery using lasers on brain tumors, with Pembrolizumab—an immune system-boosting drug—to treat recurrent Glioblastoma Multiforme (GBM).
What are the potential side effects?
Possible side effects include typical surgical risks from LITT like infection or bleeding at the site. Pembrolizumab may cause immune-related reactions affecting organs, fatigue, infusion reactions similar to allergic responses, skin rash or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood and organ function tests are within normal ranges.
Select...
My diagnosis of glioblastoma or gliosarcoma is confirmed by a pathology report.
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I completed standard treatment with radiation and Temozolomide for my primary tumor.
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I have had 3 or fewer treatments for my recurrent brain cancer.
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My tumor is 6.0 cm or smaller across.
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My tumor tissue sample is available for review.
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I can care for myself but may need occasional help.
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My tumor is located in the upper part of my brain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an autoimmune disease treated with medication in the last 2 years.
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I have or had lung inflammation not caused by an infection.
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I have been diagnosed with HIV.
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I am currently being treated for an infection.
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My tumor cannot be fully treated with a specific laser technique due to its size.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have an active Hepatitis B or C infection.
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I have another cancer that is getting worse or needs treatment.
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I have not had a live vaccine in the last 30 days.
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I have active brain metastases or cancer in the lining of my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after diagnosis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after diagnosis
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I endpoint: Optimal timing of LITT with pembrolizumab
Phase II endpoint: Tumor Response
Secondary study objectives
Overall survival (OS)
Progression free survival (PFS)
The proportion of patients who achieve progression free survival at 12 months (PFS12)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab injections 7 days before surgeryExperimental Treatment2 Interventions
Patients will have intravenous pembrolizumab 7 days before surgery with Laser Interstitial Thermotherapy
Group II: Pembrolizumab injections 35 days after surgeryExperimental Treatment2 Interventions
Patients will have intravenous pembrolizumab 35 days after surgery with Laser Interstitial Thermotherapy
Group III: Pembrolizumab injections 14 days after surgeryExperimental Treatment2 Interventions
Patients will have intravenous pembrolizumab 14 days after surgery with Laser Interstitial Thermotherapy
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
467 Previous Clinical Trials
32,621 Total Patients Enrolled
16 Trials studying Glioblastoma
526 Patients Enrolled for Glioblastoma
Andrew Sloan, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
4 Previous Clinical Trials
109 Total Patients Enrolled
3 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Tiffany Hodges, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 Previous Clinical Trials
114 Total Patients Enrolled
1 Trials studying Glioblastoma
114 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab injections 35 days after surgery
- Group 2: Pembrolizumab injections 14 days after surgery
- Group 3: Pembrolizumab injections 7 days before surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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