Study on NG101m as Additional Treatment for Glioblastoma Patients

Sponsor: NeuGATE Theranostics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04373785

Provider View

This clinical trial is testing whether adding NG101m capsules to the standard treatment of temozolomide and radiation can improve outcomes for patients with glioblastoma, a type of aggressive brain cancer.

Patient Parameters

Program Overview

The aim of this study is to see if taking NG101m capsules along with the usual treatment of temozolomide and radiation can help people with glioblastoma, a severe form of brain cancer. Glioblastoma is a very aggressive cancer, and the current standard treatment involves surgery to remove as much of the tumor as possible, followed by radiation and chemotherapy with temozolomide. This trial will evaluate if adding NG101m can improve survival rates over two years for newly diagnosed patients.

Description

Glioblastoma multiforme (GBM) is a very aggressive type of brain cancer, with about 12,000 new cases each year in the United States. The standard treatment includes surgery to remove the tumor, followed by radiation therapy and chemotherapy with a drug called temozolomide. Despite treatment, the average survival time for patients is about 14.6 months, and only about 27% of patients live for two years. This study is testing whether adding a new treatment, NG101m, to the standard therapy can help improve survival rates for patients who have just been diagnosed with GBM.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Newly diagnosed with glioblastoma multiforme (GBM).
  • Must be receiving standard treatment with chemotherapy and radiation.
  • Blood tests must show:
    • Hemoglobin level above 9 g/dL.
    • White blood cell count between 3,600 and 11,000/mm3.
    • Neutrophil count of at least 1,500/mm3.
    • Lymphocyte count of at least 1,000/mm3.
    • Platelet count of at least 100,000/mm3.
    • Normal kidney and liver function as indicated by specific blood tests.
  • Must not be using any alternative therapies.
  • Must not be pregnant.

Exclusion Criteria

  • Allergic to meloxicam, famotidine, caffeine, or their components.
  • Allergic to vitamin A, vitamin D3, or L-citrulline.
  • Pregnant or breastfeeding women.
  • Cannot reduce corticosteroid use to 1-2 mg/day of dexamethasone or equivalent.
  • History of immune system disorders or autoimmune diseases.
  • History of stomach ulcers or gastrointestinal perforation.

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