Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM) (NCT03277638) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM)
United States32 participantsStarted 2017-11-29
Plain-language summary
The purpose of this study is to test the side effects and efficacy of using Laser Interstitial Thermotherapy (LITT) combined with Pembrolizumab. LITT is a minimally invasive surgical technique that uses a laser to heat brain tumors.
Pembrolizumab is an investigational (experimental) drug that works by helping participants' immune system work correctly to detect and fight cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA), for this use, though it is approved to treat other cancers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically proven diagnosis of glioblastoma or gliosarcoma prior to registration by pathology report;
* The tumor must be confined to the supratentorial compartment
* The Formaldehyde Fixed-Paraffin Embedded tumor tissue block must be available to be sent for retrospective central pathology review after registration).
* History/physical examination within 7 days prior to registration
* Karnofsky performance status ≥ 60 within 7 days prior to registration
* Adequate Organ Function Laboratory Values
* Absolute neutrophil count (ANC) ≥1,500/mcL
* Platelets ≥100,000/mcL
* Hemoglobin ≥9.0 g/gL or ≥5.6 mmol/L, without recent transfusion
* Creatine ≤1.7 x upper limit of normal (ULN) or Measure or Calculated creatinine clearance ≥ 60.0mL/min for subject with creatinine levels \> 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
* Total bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 x ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN for subjects with liver metastases
* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines laser heat treatment (LITT) directly in the brain with the immunotherapy drug pembrolizumab — given that it's still in Phase 1/2 and one of the main goals is just figuring out the safest timing of these two treatments together, what does that mean for how much is currently known about risks versus potential benefit for someone in my situation?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any chance I could still be considered, or are there similar trials combining LITT with immunotherapy that I should be looking into instead?
3Since this targets recurrent GBM specifically, how does my current disease status — like how many times it has recurred and what prior treatments I've had — affect whether this kind of approach might even be worth pursuing?
4One of the Phase 2 goals is measuring tumor response after combining LITT with pembrolizumab — based on what's been published or presented from this trial so far, has there been any signal about how well this combination is working in recurrent GBM patients?
5Compared to other options for recurrent GBM, like repeat surgery, bevacizumab, or other immunotherapy trials, how does my doctor weigh the experimental nature of this LITT-plus-checkpoint-inhibitor approach against more established treatments at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I endpoint: Optimal timing of LITT with pembrolizumab
Timeframe: Up to 24 months after beginning Pembrolizumab
2
Phase II endpoint: Tumor Response
Timeframe: Up to 24 months after beginning Pembrolizumab