Trial | NCT04373785  Report issue

Title

NG101m Adjuvant Therapy in Glioblastoma Patients
A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Not yet recruiting

  • Study Participants

    52
The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.
Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal, safe resection, followed by radiation therapy of 60 Gray (Gy) with concomitant oral temozolomide (TMZ) for 6 weeks, then continue with six cycles of high-dose temozolomide. The median survival rate for newly diagnosed GBM patients is 14.6 months with a 2-year overall survival (OS) rate of 27.2%. This clinical trial evaluates the 2-year OS of oral NG101m as an adjuvant therapy to chemoradiotherapy in newly diagnosed GBM subjects.
Study Started
Jan 01
2024
Anticipated
Primary Completion
Jul 30
2027
Anticipated
Study Completion
Dec 31
2027
Anticipated
Last Update
Apr 18
2023

Radiation Intensity-modulated radiation therapy

Intensity-modulated radiation therapy (IMRT) in daily fractions of 2.67 Gy given 5 days per week for 3 weeks, for a total of 40.05 Gy.

  • Other names: radiation therapy

Drug Temozolomide

Oral temozolomide (75 mg/m2), given 5 days per week, for 3 weeks during radiotherapy. 1 month after the discontinuation of radiotherapy, oral temozolomide is restarted at 150 to 200 mg/m2 for 5 days during each 28-day cycle for 12 cycles.

  • Other names: Temodar

Drug NG101m

Oral NG101m capsule continuously twice daily.

  • Other names: NG101m regimen

NG101m and standard treatment Experimental

Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

Criteria 

Inclusion Criteria:

Male or female subjects ≥ 18 years of age
Must be newly diagnosed with GBM
Primary treatment must consist of a chemoradiation therapy (CRT) regimen
Hemoglobin > 9 g/dL
White blood count 3,600 - 11,000/mm3
Absolute neutrophil count (ANC) ≥ 1,500/mm3
Absolute lymphocyte count (ALC) ≥ 1,000/mm3
Platelet count 100,000/mm3
BUN ≤ 1.5 times upper limit of normal
Creatinine clearance rate > 40 mL/min
ALT ≤ 3 times upper limit of normal
AST ≤ 3 times upper limit of normal
Alkaline phosphatase ≤ 3 times upper limit of normal
Total bilirubin ≤ 2.0 mg/dL
Karnofsky Performance Status ≥ 70
Must not be on any other alternative therapies
Not pregnant

Exclusion Criteria:

Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components
Known allergy to vitamin A, vitamin D3, and/or L-citrulline
Pregnant women
Breastfeeding women
Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent
History of immunodeficiency diseases or autoimmune diseases
History of peptic ulcer disease or gastrointestinal perforation
No Results Posted