Testing the Addition of Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04729959

Provider View

This study is exploring whether adding the immune therapy drugs tocilizumab and atezolizumab to radiation therapy can help treat glioblastoma that has returned after initial treatment. The goal is to see if this combination can shrink or stabilize the cancer better than radiation alone.

Patient Parameters

Program Overview

This phase II trial is testing if combining the immune therapy drugs tocilizumab and atezolizumab with precise radiation therapy can help treat glioblastoma that has come back after initial treatment. Tocilizumab may help reduce inflammation, while atezolizumab may help the immune system attack cancer cells. The study aims to see if this combination can make the tumor more responsive to treatment and improve outcomes for patients with recurrent glioblastoma.

Description

The study is divided into different parts to test the safety and effectiveness of the treatment combination.

Primary Objectives:

  • Determine the safest dose levels of tocilizumab and atezolizumab with radiation therapy.
  • Evaluate how well this combination works in shrinking tumors in patients with recurrent glioblastoma.

Secondary Objectives:

  • Estimate how long patients live without the cancer getting worse.
  • Estimate overall survival rates for patients receiving the treatment.
  • Assess the side effects of the treatment combination.

Exploratory Objectives:

  • Study the effects of the treatment on the immune environment around the tumor.
  • Evaluate changes in immune cells in the blood.
  • Identify markers in the tumor or blood that may be linked to treatment outcomes.

Study Outline:

  • Safety Run-In: Patients receive tocilizumab with or without atezolizumab and undergo radiation therapy. Treatment is repeated every 4 weeks for up to 2 years if the cancer does not progress or cause unacceptable side effects.
  • Non-Surgical Cohort: Similar treatment as the safety run-in, with regular MRI scans to monitor progress.
  • Surgical Cohort: Patients are divided into two groups. One group receives tocilizumab with or without atezolizumab and radiation, followed by surgery. The other group receives atezolizumab and radiation, followed by surgery. Treatment is repeated every 4 weeks for up to 2 years if the cancer does not progress or cause unacceptable side effects.

After completing the study treatment, patients are followed up at regular intervals to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma, either by tissue sample or specific molecular criteria.
  • Tumor has returned after initial radiation treatment.
  • Clear evidence of tumor growth on an MRI scan.
  • Tumor suitable for targeted radiation therapy.
  • For surgical cohort: Must be a candidate for surgery to remove the tumor.
  • Available information on tumor's MGMT methylation status.
  • Specific time intervals must have passed since previous treatments.
  • Age 18 or older.
  • Good overall health with a performance status of 70 or higher.
  • Adequate blood cell counts and organ function.
  • Agree to use effective contraception during and after the study.
  • Negative pregnancy test for women of childbearing potential.
  • HIV-positive patients must have controlled viral load and stable treatment.
  • Hepatitis B and C infections must be controlled or treated.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Known mutations in IDH1 or IDH2 genes.
  • Known DNA repair defects.
  • Tumor spread to brainstem or spinal cord.
  • Significant brain swelling or shift.
  • Previous treatment with certain cancer drugs.
  • Recent use of immunostimulatory or immunosuppressive medications.
  • High doses of steroids for brain swelling.
  • Risk of gastrointestinal perforations.
  • Severe allergies to certain medications.
  • Significant liver disease or autoimmune conditions.
  • History of lung diseases like pneumonitis.
  • Active tuberculosis or severe infections.
  • Recent major surgery or live vaccines.
  • Uncontrolled health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.

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