Earlier this month, Providence Saint John’s Health Center Foundationannounced^[1] a breakthrough Clinical Trial^[2] for Brain Tumor patients. Dr Santosh Kesari (An Indian-American Oncologist) will conduct this trial at the Pacific Neuroscience Institute, John Wayne Cancer Institute and Providence Saint John’s Health Center.

Who is Dr Santosh Kesari?

Dr. Santosh Kesari is a board-certified neurologist and neuro-oncologist, ranked among the top 1% of neuro-oncologists in the US, according to Castle Connolly Medical Ltd. He is a part of the American Brain Tumor Association, the San Diego Brain Tumor Foundation and the Philippine Brain Tumor Alliance.

What is Glioblastoma?

 

According to Dr Kesari, “This is an aggressive and lethal form of Brain Cancerthat carries a very poor prognosis of 14-16 months survival. The tumor generally has a main mass that can be surgically debulked in many cases. However, in this cancer type, additional tumor cells extensively invade normal brain tissue and cannot be surgically removed without causing damage.”

 

Standard treatment procedures for this Cancer type have generally included surgical intervention and/or Chemotherapy. However, a strong array of side effects of Chemotherapy often tends to affect patients in a worse manner, and this leads to poor outcomes. Dr Kesari’s team aims to solve this problem using Precision Immunotherapy.

What is Precision Immunotherapy?

 

Dr Kesari and his team will use a protocol called Precision Immunotherapy in the Neoadjuvant Setting (or PIN) to provide a working alternative Immunotherapy option to newly diagnosed Glioblastoma patients.

This clinical trial will approach Glioblastoma treatment in a whole new way, by beginning the treatment with Immunotherapy instead of Radiation or Chemotherapy. This way, the patient’s immune system will remain unaffected. In turn, this is expected to generate better responses and patient outcomes.

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Who is eligible for a Clinical Trial with the PIN Protocol?

 

The PIN protocol is designed for difficult-to-treat patients, who have not received either Chemotherapy or Radiation. This ensures that their immune systems have not been compromised.

What medicines will Dr Santosh Kesari’s Clinial Trial use?

The Glioblastoma trial will take a three-armed approach. It will compete with standard (existing) care modalitites with two immunotherapy drugs that can target unique Immune Checkpoint Inhibitor Pathways to stop the rapid proliferation of cancer cells.

Researchers will collect and analyze biospecimens, including blood and CSF to get insights into anti-tumor activities of the drugs being studied, and to understand patterns within the biomarker characteristics of responders.

When will this Clinical Trial start?

The Phase One Foundation has made an initial investment of $300,000 for this trial and research. According to Dr Kesari and team, the PIN trial will commence immediately, and will begin recruiting patients at the earliest.

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“We are hopeful about this approach which represents a real paradigm shift in the treatment of newly diagnosed glioblastoma patients. The standard treatments using radiation and chemotherapy diminish the patient’s immune system. The benefit of treating the patient before standard therapy should in theory allow the patient to respond to immunotherapy more strongly and fight the cancer more effectively.” – Dr Santosh Kesari

1. ndiaWest Publication Announcing The Trial ↩︎
2. List Of Clinical Trials at Providence Saint John’s ↩︎