Dr. Santosh Kesari, Principal Investigator, Oversees Open Neurological & Brain Cancer Clinical Trials
Dr. Santosh Kesari of the Pacific Neuroscience Institute is the principal investigator for more than a dozen clinical trials, of which 8 are brain tumor-related. Dr. Kesari is the Chair and Professor of the Department of Translational Neuro-oncology and Neurotherapeutics at Saint John’s Cancer Institute. He is ranked among the top 1 percent of neuro-oncologist and neurologists in the nation, according to Castle Connolly Medical Ltd, and is an internationally recognized scientist and clinician.
Transforming biomedical research and medicine into promising new treatments used clinically starts here at Saint John’s Cancer Institute.
Ongoing Trials for Brain Tumors, Neuroscience
Caris Biorepository Research Protocol
Advancing precision medicine for patients
Summary:
The Caris Biorepository is a collection of biological specimens including clinical and demographic data that will be used and shared for research. Caris Life Sciences will maintain the data and specimens, and control access to information and specimens. This is an observational, group study.
Trial Objective:
The objective is to develop and implement a state-of-the-science biorepository, providing vital biospecimens and data to internal researchers and external research partners. Collaborators include government, academic institutions, and other industry firms will work together to advance drug development discoveries, which helps to guide other research trials and future healthcare policies.
Estimated number of participants: 100,000
Start Date: November 2010
End Date: November 2020
Conclusion of the study: November 2025
Link to Study at clinicaltrials.gov
Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository
Advancing precision medicine for patients
Summary:
Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment.
Caris Life Sciences and Precision Oncology Alliance Retrospective Outcomes-Associated Database
Advancing precision medicine for patients
Summary:
This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a “real world” perspective on diagnosis, treatment, cost, and outcomes
A Longitudinal Assessment of Tumor Evolution in Patient with Brain Cancer
Assessing the safety of drugs in patients with brain cancer
Summary:
The purpose of this study is to test the safety and tolerability of certain drugs when given to patients after surgery, and before receiving radiation treatment and temozolomide (a chemotherapy medication). The trial focuses on patients with newly diagnosed, high-grade glioma—a tumor that occurs in the brain and spinal cord and develops from specialized cells that support neurons.
Trial Objective:
The objective of this study to determine if there will be any side effects (good or bad) due to the drug combinations while evaluating any preliminary evidence of anti-cancer activity. The trial will also examine tumor characteristics by collecting brain tumor tissue samples, measuring the number of drugs in biospecimens, and assessing biomarkers.
Estimated number of participants: 90
Start Date: March 1, 2018
End Date: March 1, 2022
Conclusion of the study: March 2022
Link to Study at clinicaltrials.gov
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
Advancing precision medicine for patients
Summary:
This Phase II study investigates how the body tolerates, absorbs, and removes properties of OKN-007, a drug that may stop tumor growth by blocking enzymes needed for cell growth. The trial targets patients with recurring malignant brain tumors called glioblastomas, which develop from specific brain cells called astrocytes. Patients are required to have been previously treated, including with surgery, radiation therapy, chemotherapy, and in some cases, treatment for recurrent disease.
Trial Objective:
To measure neurologic function and performance, adverse events, and collect blood plasma for future study.
Estimated number of participants: 56
Start Date: June 12, 2020
End Date: May 25, 2022
Conclusion of the study: October 25, 2022
Link to Study at clinicaltrials.gov
Liquid Biopsy Evaluation Of Biomarkers In Various Clinical Specimen Types From Patients With Cancer
Advancing precision medicine for patients
Summary:
Liquid biopsy specimen collections will be obtained prospectively from multiple clinics for the evaluation of various non-blood bodily fluid sample types such as cerebrospinal fluid (CSF), pleural fluid, bronchial washings, ascites fluid, amniotic fluid, saliva, sputum, urine, etc. The study is intended to assess the feasibility of interrogating these sample types for molecular profiling with Biocept Target Selector™ liquid biopsy methodologies that are either offered on the company’s current commercial test menu or are in development. Prospectively collected blood samples will also be collected from patients for the purpose of clinical validation of new Biocept Target Selector™ assays and/or cancer types that are not on the company’s current commercial test menu.
A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First-Line Therapy
Advancing precision medicine for patients
Summary:
A study of Berubicin in adult subjects with recurrent glioblastoma multiforme
Trial Objective:
After relapse or failure of their initial treatment, patients with glioblastoma will either receive investigational treatment with Berubicin (an anti-cancer drug) or standard treatment with lomustine oral chemotherapy. Patients will be randomized to treatment groups and are two times more likely to receive Berubicin. Comparisons of overall response and survival outcomes will be evaluated to determine efficacy and safety.
Estimated number of participants: 210
Start Date: May 18, 2021
End Date: October 2024
Conclusion of the study: February 2025
Link to Study at clinicaltrials.gov
Neurological Outcomes in Health and Disease
Advancing precision medicine for patients
Summary:
This is a non-therapeutic, non-interventional, prospective study. A comprehensive analysis of systematically collected functional and anatomical imaging modalities, histopathology, genotyping, profiling, and clinical data will allow for better prediction of outcome, optimization of treatment, and ultimately, personalized treatment of brain tumors and neurological disorders.
A Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed Glioblastoma
Advancing precision medicine for patients
Summary:
To test the effectiveness and safety of Optune® (a wearable, FDA-approved treatment for glioblastoma) given together with radiation therapy and temozolomide (a type of chemotherapy for brain tumors) in newly diagnosed glioblastoma patients, compared to radiation therapy and temozolomide alone. Optune® and maintenance temozolomide is continued following radiation therapy.
Estimated number of participants: 950
Start Date: December 8, 2020
End Date: August 2024
Conclusion of the study: August 2026
Link to Study at clinicaltrials.gov
Prospective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib (Prospective Non-interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib)
Advancing precision medicine for patients
Summary:
This observational study seeks to assess the safety and effectiveness of larotrectinib (a cancer-inhibiting medication) in patients with locally advanced or metastatic TRK fusion cancer. Patients who have decided to treat with larotrectinib will have the opportunity to be followed throughout the duration of their treatment to investigate side effects, response, and general outcomes.
Estimated number of participants: 300
Start Date: April 3, 2020
End Date: November 30, 2029
Conclusion of the study: March 31, 2030
Link to Study at clinicaltrials.gov
A Phase 1/2 Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
Advancing precision medicine for patients
Summary:
This first-in-human study investigates the safety and tolerability of PBI-200, a novel oral therapy developed with very high TRK selectivity to treat advanced or metastatic cancers that express the NTRK gene fusion, NTRK amplification, or EWSR1-WT1 fusion. In Phase 1 of this study, the dose will be incrementally increased to determine which is the safest and most effective. Once the recommended dose is established the study will proceed to Phase 2 in which further investigation of PBI-200’s antitumor activity will take place.
Phase 1 trial of intravenous administration of TAEKVAC- HerBy vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.
This study is a phase 1 open-label vaccine (TAEK-VAC-HerBy) in patients with advanced brachyury (a tumor-specific antigen) and/or HER2 expressing cancer. Patients will receive the vaccine intravenously every three weeks for a total of three doses.
Estimated number of participants: 55
Start Date: August 10, 2020
End Date: January 2024
Conclusion of the study: January 2026
Link to Study at clinicaltrials.gov
An Open-label, Nonrandomized, Phase 1 Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of Belinostat in Combination with Atazanavir in Patients with Advanced Relapsed/Refractory Solid Tumors or Hematological Malignancies
Advancing precision medicine for patients
Summary:
Patients with advanced solid tumors that have exhausted standard salvage therapy options will receive a total of two cycles of belinostat infusions, an approved treatment for relapsed/refractory peripheral T-cell lymphoma. An oral antiretroviral medication, atazanavir, will be given in combination and evaluated for potential drug-to-drug interactions with belinostat.
Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High-Grade Gliomas.
This is an expanded access study that aims to provide eligible patients of clinical neuroendocrine trial ONC201 with an anti-cancer compound that targets small oncology molecules. Eligible patients would be required to present with one of; a). glioma that is positive for the H3 K27M mutation, b). grade III or IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord; or c). diffuse intrinsic pontine glioma (DIPG).
Link to Study at clinicaltrials.gov
Pemetrexed for the Treatment of Chordoma
The purpose of this study is to test the safety and tolerability of Pemetrexed—a chemical compound used to treat certain types of cancers—administered to people with chordoma (a rare type of cancerous tumor that can occur anywhere along the spine). This study will also assess the side effects, growth, and characteristics of cancer cells, and review biomarkers to measure disease progression.
Estimated number of participants: 15
Start Date: September 6, 2019
End Date: May 31, 2022
Conclusion of the study: May 31, 2023
Link to Study at clinicaltrials.gov
Principal Investigator:
Chair, Department of Translational Neurosciences
Director of Neuro-oncology
Pacific Neuroscience Institute
Saint John’s Cancer Institute
The Saint John’s Cancer Institute maintains a robust biospecimen tissue bank and has demonstrated sustained scientific quality, resources, and storage systems for the effective management of human tissues.