Trial of AEO in New Glioblastoma (GBM)
Paraules clau
Resum
Descripció
Currently, the multidisciplinary Standard of Care treatment for Glioblastoma multiforme includes maximal surgical resection of the tumor followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy.This study will treat newly diagnosed GBM patients by adding Anhydrous Enol-Oxaloacetate treatment to their current Standard of Care.
In the body, Anhydrous Enol-Oxaloacetate (AEO) converts into "Oxaloacetate", a metabolite important for many biochemical reactions in the body. On a cellular level, oxaloacetate treatment has been found to modify cancer metabolism in GBM cells, reversing the "Warburg Effect", reducing glycolysis and reducing lactate production. In animals, oxaloacetate treatment has increased survival and reduced tumor growth of implanted GBM tumors.
In other animal studies, oxaloacetate has also shown to have neuo-protective effects including positive effects on seizure development.
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Dates
| Darrera verificació: | 05/31/2020 |
| Primer enviat: | 06/22/2020 |
| Inscripció estimada enviada: | 06/24/2020 |
| Publicat per primera vegada: | 06/28/2020 |
| Última actualització enviada: | 06/24/2020 |
| Publicació de l'última actualització: | 06/28/2020 |
| Data d'inici de l'estudi real: | 11/30/2020 |
| Data estimada de finalització primària: | 06/30/2022 |
| Data estimada de finalització de l’estudi: | 08/31/2022 |
Condició o malaltia
Intervenció / tractament
Drug: AEO with Standard of Care
Other: Standard of Care
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Placebo Comparator: Standard of Care Current GBM Treatment of surgery, radiation and chemotherapy with temozolomide. | |
| Experimental: AEO with Standard of Care Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide). | Drug: AEO with Standard of Care Oral supplementation with AEO along with the Standard of Care (Temozolomide) |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - • Histopathologic diagnosis of glioblastoma multiforme - Standard of care maximal feasible surgical resection of the glioma - Post-operative pre-enrollment MRI-Note: measurable disease is not required - Concomitant anti-epileptic drugs - Hemoglobin >9 g/dL - Platelets >100,000/microliter (mcL) - <3.0 Upper Limit of Normal Range (ULN) for Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and/or Alkaline Phosphatase - <2.0 Upper Limit of Normal Range (ULN) for serum creatinine - Karnofsky performance status >70 - Mentally competent to follow study procedures - Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug until 90 days after the last dose of study drug - Able to answer questions on the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - Subject is willing and able to give informed consent and to follow instructions as per the protocol Exclusion Criteria: - • Concomitant treatment with carmustine wafers or tumor-treating electric fields (TTFields) - QT Interval corrected with the fridericia formula (QTcF) >480ms - Significant concurrent illness / disease - Predicted life expectancy < 6 months from date of randomization - Pregnancy - Enrollment in another clinical trial during the course of the study |
Resultat
Mesures de resultats primaris
1. Overall Survival [6 months]
2. Progression Free Survival-6 [6 months]
Mesures de resultats secundaris
1. Seizures [6 months]
2. Chalfont-National Hospital Seizure Severity [6 months]
3. PROMIS-Cancer - Fatigue [6 months]
