NG101m Adjuvant Therapy for Glioblastoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NeuGATE Theranostics

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if adding NG101m capsules to standard brain cancer treatments can help patients with newly diagnosed glioblastoma multiforme live longer. NG101m is expected to make chemotherapy and radiation more effective.

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed glioblastoma who are set to start chemoradiation therapy. They must have certain blood and organ function levels, not be pregnant or breastfeeding, and can't be on other therapies or have specific allergies or diseases like immunodeficiency or autoimmune disorders.

Inclusion Criteria

BUN ≤ 1.5 times upper limit of normal

Platelet count 100,000/mm3

My main treatment is a combination of chemotherapy and radiation.

Exclusion Criteria

I cannot reduce my steroid medication to a low dose.

Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components

Pregnant women

Treatment Details

Interventions

• Intensity-modulated radiation therapy (Radiation)
• NG101m (Virus Therapy)
• Temozolomide (Alkylating agents)

Trial Overview The trial tests NG101m capsules as an add-on to the standard glioblastoma treatment, which includes temozolomide chemotherapy and intensity-modulated radiation therapy. The goal is to see if adding NG101m improves outcomes.

Participant Groups

Group I: NG101m and standard treatment Experimental Treatment 3 Interventions

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

Intensity-modulated radiation therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

🇺🇸 Approved in United States as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

🇨🇦 Approved in Canada as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

🇯🇵 Approved in Japan as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

🇨🇳 Approved in China as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

🇨🇭 Approved in Switzerland as IMRT for:

• Rectal cancer
• Gastrointestinal cancers
• Gynecologic cancers
• Central nervous system tumors
• Spinal tumors
• Head and neck malignancies
• Thoracic malignancies
• Abdominal malignancies
• Pelvic malignancies

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yvonne Kew MD, PLLC Houston, TX

Who Is Running the Clinical Trial?

NeuGATE Theranostics Lead Sponsor

References