NG101m Adjuvant Therapy in Glioblastoma Patients

NeuGATE Theranostics

Status and phase: Begins enrollment in 10 months; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Drug: NG101m; Radiation: Intensity-modulated radiation therapy; Drug: Temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04373785

NG101m

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

NG101m and standard treatment

Experimental group

Description:

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

Treatment:

Drug: Temozolomide

Radiation: Intensity-modulated radiation therapy

Drug: NG101m