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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Radiation: Intensity-modulated radiation therapy; Drug: Temozolomide; Drug: NG101m

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Yvonne Kew MD, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NG101m and standard treatment; Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Assess the duration of PFS	24 months
Response assessment in neuro-oncology (RANO) criteria	Radiological response to adjuvant NG101m therapy	24 months
Quality of Life (QoL)	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify and quantify immune/effector cells	Cytokines measurement	24 months

Collaborators and Investigators

• Sponsor: NeuGATE Theranostics

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): July 30, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: NG101m

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No