NG101m Adjuvant Therapy in Glioblastoma Patients

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04373785
• Other study ID #: NG101m
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: NeuGATE Theranostics
• Contact: Thien Tran, PharmD
• Phone: 713-534-1300
• Email: TTran[@]NeuGATE.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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.

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.
• NG101m
Oral NG101m capsule continuously twice daily.

Locations

Country	Name	City	State
United States	Yvonne Kew MD, PLLC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeuGATE Theranostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify and quantify immune/effector cells	Cytokines measurement	24 months
Primary	Number of participants with treatment-emergent adverse events and serious adverse events	Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy	1 month
Primary	Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.	Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.	24 months
Secondary	Progression-free survival (PFS)	Assess the duration of PFS	24 months
Secondary	Response assessment in neuro-oncology (RANO) criteria	Radiological response to adjuvant NG101m therapy	24 months
Secondary	Quality of Life (QoL)	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	24 months