Study on Laser Therapy Combined with Immunotherapy for Recurrent Brain Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03277638

Provider View

This clinical trial is testing a new treatment that combines laser therapy with an experimental drug, Pembrolizumab, to see if it can help treat recurrent brain cancer. The study aims to find out if this combination is safe and effective in shrinking tumors.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of using Laser Interstitial Thermotherapy (LITT) along with Pembrolizumab for treating recurrent glioblastoma (rGBM). LITT is a minimally invasive procedure that uses a laser to heat and destroy brain tumors. Pembrolizumab is an experimental drug that helps the immune system detect and fight cancer cells. Although Pembrolizumab is approved for other cancers, it is not yet approved for this specific use by the FDA.

Description

The study has two main phases:

  • Phase I: This phase will determine the best timing for combining LITT and Pembrolizumab in patients with recurrent glioblastoma. It will assess the safety and side effects of the treatment when Pembrolizumab is given at different times before or after LITT.

  • Phase II: This phase will evaluate how well the combination of LITT and Pembrolizumab works in shrinking tumors in patients with recurrent glioblastoma. It will also continue to monitor the safety and side effects of the treatment.

Secondary goals include understanding how Pembrolizumab affects the immune environment in the body and within the tumor, as well as measuring how long patients live without the cancer progressing and their overall survival. The study will also use advanced imaging techniques to assess the response of the tumors to the treatment and correlate these findings with known genetic markers of glioblastoma.

The study will involve several groups of patients, each receiving Pembrolizumab at different times relative to the LITT procedure. The goal is to find the earliest time after LITT that Pembrolizumab can be safely given to achieve the best results.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma or gliosarcoma.
  • Tumor located in the upper part of the brain.
  • Available tumor tissue sample for review.
  • Recent medical examination and good overall health.
  • Adequate blood cell counts and organ function based on lab tests.
  • Completed previous standard treatment with radiation and chemotherapy.
  • No more than three prior treatments for recurrent high-grade glioma.
  • Ability to understand and sign informed consent.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Men must agree to use contraception during the study.
  • Tumor size and location must be suitable for LITT treatment.
  • Tumor must be a single focus and stable if there are additional small lesions.

Exclusion Criteria

  • Previous use of certain immunotherapies or vaccines.
  • History of other invasive cancers unless disease-free for at least 3 years.
  • Severe heart conditions or recent heart attack.
  • Recent stroke or serious heart rhythm problems.
  • Significant vascular disease or bleeding disorders.
  • Serious infections or respiratory illnesses.
  • Liver disease causing jaundice or blood clotting issues.
  • Autoimmune diseases requiring treatment.
  • Active infections or conditions affecting the immune system.
  • Pregnant or breastfeeding women.
  • Previous treatment with Pembrolizumab or similar drugs.
  • Known HIV or active hepatitis B or C infections.
  • Recent live vaccine administration.
  • Severe allergic reactions to monoclonal antibodies.
  • Inability to undergo MRI scans.
  • Tumors not suitable for effective LITT treatment.

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