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NG101m Adjuvant Therapy in Glioblastoma Patients

Primary Purpose

Glioblastoma Multiforme

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intensity-modulated radiation therapy

Temozolomide

NG101m

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Yvonne Kew MD, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NG101m and standard treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events and serious adverse events

Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy

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.

Secondary Outcome Measures

Progression-free survival (PFS)

Assess the duration of PFS

Response assessment in neuro-oncology (RANO) criteria

Radiological response to adjuvant NG101m therapy

Quality of Life (QoL)

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Full Information

NCT ID

NCT04373785

First Posted

April 30, 2020

Last Updated

April 13, 2023

Sponsor

NeuGATE Theranostics

1. Study Identification

Unique Protocol Identification Number

NCT04373785

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

July 30, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuGATE Theranostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NG101m and standard treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiation therapy

Other Intervention Name(s)

radiation therapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NG101m

Other Intervention Name(s)

NG101m regimen

Intervention Description

Oral NG101m capsule continuously twice daily.

Primary Outcome Measure Information:

Title

Number of participants with treatment-emergent adverse events and serious adverse events

Description

Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy

Time Frame

1 month

Title

Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.

Description

Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Assess the duration of PFS

Time Frame

24 months

Title

Response assessment in neuro-oncology (RANO) criteria

Description

Radiological response to adjuvant NG101m therapy

Time Frame

24 months

Title

Quality of Life (QoL)

Description

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Identify and quantify immune/effector cells

Description

Cytokines measurement

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thien Tran, PharmD

Phone

713-534-1300

TTran@NeuGATE.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yvonne Kew, MD, PhD

Organizational Affiliation

NeuGATE Theranostics

Official's Role

Study Director

Facility Information:

Facility Name

Yvonne Kew MD, PLLC

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thien Tran, Pharm.D.

Phone

713-534-1300

Thien@DrKew.com

First Name & Middle Initial & Last Name & Degree

Yvonne Kew, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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NG101m Adjuvant Therapy in Glioblastoma Patients

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