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NG101m Adjuvant Therapy in Glioblastoma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04373785
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NeuGATE Theranostics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yvonne Kew, MD, PhD
Principal Investigator Affiliation NeuGATE Theranostics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: NG101m and standard treatment

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

Interventions

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.

Drug: - NG101m

Oral NG101m capsule continuously twice daily.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yvonne Kew MD, PLLC, Houston, Texas

Status

Address

Yvonne Kew MD, PLLC

Houston, Texas, 77030

Site Contact

Thien Tran, Pharm.D.

[email protected]

713-534-1300

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