Study on Radiation, Temozolomide, and Immunotherapy with Daratumumab to Improve Treatment in Glioblastoma

Sponsor: West Virginia University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04922723

Provider View

This clinical trial is exploring whether adding the immunotherapy drug Daratumumab to standard treatments of radiation and Temozolomide can enhance the effectiveness against glioblastoma, a type of aggressive brain cancer. The study will involve about 16 participants.

Patient Parameters

Program Overview

The study aims to find out if combining Daratumumab, an immunotherapy drug, with the standard treatment of Temozolomide (TMZ) and radiation can improve outcomes for patients with glioblastoma (GBM), a severe form of brain cancer. Daratumumab is believed to work well with chemotherapy and radiation, and it can reach the brain effectively. The trial will include two phases, with a total of 16 participants.

Description

Glioblastoma (GBM) is a fast-growing brain cancer. The usual treatment involves surgery to remove as much of the tumor as possible, followed by chemotherapy with Temozolomide (TMZ) and radiation therapy. However, the cancer often comes back. This study is testing whether adding Daratumumab, a drug that targets cancer cells, can improve treatment results for newly diagnosed GBM patients. Daratumumab has shown promise in pre-clinical studies and is safe when used with chemotherapy and radiation. The study will enroll 16 participants in two phases to evaluate the safety and effectiveness of this combination treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a high likelihood of glioblastoma based on scans and plan for surgery or biopsy to confirm.
  • Must be in good general health with a performance status of 2 or less, meaning able to carry out light work.
  • Must have normal blood and organ function, including:
    • White blood cell count of at least 3,000/mcL
    • Neutrophil count of at least 1,500/mcL
    • Platelet count of at least 100,000/mcL
    • Normal liver and kidney function
  • Women and men must agree to use effective birth control during the study and for a period after treatment.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C must have the virus under control.
  • Patients with other cancers can join if it does not interfere with the study.
  • Must have a heart health assessment if there is a history of heart disease.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have received prior treatment for glioblastoma.
  • Are taking other experimental drugs.
  • Have allergies to Daratumumab or Temozolomide.
  • Are taking certain medications that interact with Daratumumab or Temozolomide.
  • Have uncontrolled illnesses or psychiatric conditions that prevent following the study.
  • Are pregnant or breastfeeding, as the effects of Daratumumab during pregnancy are unknown, and Temozolomide may harm the fetus.
  • Have severe lung conditions like COPD with low lung function.
  • Have moderate or severe asthma that is not well-controlled.
  • Have significant heart disease, such as recent heart attack or unstable heart conditions.

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