Study on DC Migration to Evaluate TReg Depletion in Glioblastoma Patients With and Without Varlilumab

Sponsor: Annick Desjardins, MD

Sponsor score: 0

ClinicalTrials ID:NCT03688178

Provider View

This clinical trial is exploring a new treatment approach for patients with newly diagnosed glioblastoma, a type of brain cancer. The study involves using dendritic cell vaccines and evaluating the effects of an additional drug, varlilumab, to see if it helps improve the immune response against the cancer.

Patient Parameters

Program Overview

Patients with newly diagnosed glioblastoma will participate in this study after their tumor has been surgically removed. They will undergo a procedure to collect white blood cells, which will be used to create dendritic cell vaccines. These vaccines are designed to help the immune system recognize and attack cancer cells. Participants will also receive standard radiation therapy and a chemotherapy drug called temozolomide. The study will test different pre-treatment methods before giving the dendritic cell vaccines, including the use of a drug called varlilumab, to see if it enhances the immune response.

Description

Glioblastoma is a type of brain cancer that is difficult to treat. This study is testing a new approach that uses the body's immune system to fight the cancer. Researchers will create special vaccines from the patient's own white blood cells, which are designed to target a virus protein found in many glioblastoma tumors. These vaccines aim to help the immune system recognize and attack the cancer cells more effectively.

Participants will receive standard treatment with radiation and a chemotherapy drug called temozolomide. They will also receive up to 10 doses of the dendritic cell vaccines. The study will test different methods of preparing the body before giving the vaccines, including using a tetanus-diphtheria shot and a drug called varlilumab, which may help boost the immune response.

The study will compare three groups of patients to see which pre-treatment method works best. One group will receive a tetanus-diphtheria shot before the vaccines, another group will receive a different type of pre-treatment, and the third group will receive varlilumab along with the tetanus-diphtheria shot. The goal is to find out if these methods can improve the effectiveness of the vaccines in fighting glioblastoma.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older.
  • Diagnosed with glioblastoma and have had surgery to remove the tumor.
  • Able to receive standard radiation and chemotherapy treatment.
  • Have a small amount of cancer remaining after surgery, as seen on a scan.
  • Have enough tumor tissue available for testing.
  • Test positive for CMV, a common virus.
  • Have a good performance status, meaning able to carry out daily activities.
  • Meet specific blood test requirements for hemoglobin, white blood cells, and platelets.
  • Have normal kidney and liver function based on blood tests.
  • Women must not be pregnant or breastfeeding and must use effective birth control during the study and for six months after.
  • Men must agree to use effective birth control during the study and for six months after.
  • Must sign an informed consent form to participate.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Individuals not willing to use effective birth control.
  • Allergic to certain MRI contrast agents.
  • Unable to have an MRI due to metal implants or obesity.
  • Have cancer in certain parts of the brain or spine, or have multiple tumors.
  • Have severe health conditions like heart failure or infections requiring hospitalization.
  • Have liver problems causing jaundice.
  • Have HIV or Hepatitis C.
  • Have other serious medical or psychiatric conditions.
  • Taking medications that could interfere with the study.
  • Have had other cancers requiring active treatment, except for certain skin cancers.
  • Have participated in another experimental drug study recently.
  • Have a history of autoimmune diseases, except for controlled hypothyroidism or Type I Diabetes.

Locations

FACILITYZIPCITYSTATE
Duke University Medical Center27710DurhamNorth Carolina

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