Clinical trial NCT04373785: NG101m Adjuvant Therapy in Glioblastoma Patients
Official title: A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: NeuGATE Theranostics
Sponsor class: INDUSTRY
First posted: 2020-05-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events and serious adverse events
timeFrame: 1 month
measure: Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Response assessment in neuro-oncology (RANO) criteria
timeFrame: 24 months
measure: Quality of Life (QoL)
timeFrame: 24 months
Other outcomes:
measure: Identify and quantify immune/effector cells
timeFrame: 24 months
Locations:
city: Houston
country: United States
facility: Yvonne Kew MD, PLLC
state: Texas
Study officials:
affiliation: NeuGATE Theranostics
name: Yvonne Kew, MD, PhD
role: STUDY_DIRECTOR
References: