Baptist Health South Florida, Miami Cancer Institute

Miami Cancer Institute Launches Trial of Azeliragon with Stereotactic Radiosurgery in Patients with Brain Metastases

January 29, 2024

MIAMI, FL – January 29, 2024 – Physician-researchers at Miami Cancer Institute, part of Baptist Health South Florida, recently launched a clinical trial that studies the combination of a new medication and stereotactic radiosurgery in patients with brain metastases. The therapy combines azeliragon, a blood brain barrier-permeating antagonist of the receptor for advanced glycation end products (RAGE) that is known to affect inflammation, with radiosurgery. The researchers hope the combination therapy will improve outcomes in patients with brain metastases who often have few treatment options.

“The ultimate aim of the study is to find an innovative new approach to reducing tumors, preventing brain inflammation that can follow radiation therapy, and potentially protecting neurocognitive function,” said Rupesh Kotecha, M.D., chief of radiosurgery, director of the Central Nervous System Metastasis Program at Miami Cancer Institute, and principal investigator of the trial. “This is an exciting new combinatorial regimen as it has the potential to overcome cancer’s resistance pathways and improve response rates.”

In the United States, between 200,000 and 300,000 patients are diagnosed with brain metastases each year. The most common primary cancers that metastasize to the brain are lung, breast, melanoma, and kidney tumors. Brain metastases are particularly challenging to treat, usually with a combination of therapies meant to extend life and improve quality of life, but they rarely can be cured. The advancement of stereotactic radiosurgery over the past decade has made it possible for patients to receive a high dose of radiation precisely to the tumor, sparing important nearby brain structures. In addition, azeliragon has been shown to help mediate against radiation resistance, protect against neuroinflammation, and preserve neurocognitive function.

“This clinical trial will determine the maximum safe dosage of the medication to be given with radiosurgery, while also tapering corticosteroids,” said Yazmin Odia, M.D., M.S., FAAN, chief of neuro-oncology at Miami Cancer Institute, and co-leader of the trial at the Institute. “At the maximum safe dose, the study will determine effectiveness in protection against neuroinflammation, lessening a tumor’s resistance to radiation, reducing tumor size, and maintaining or improving quality of life.”

The study, “A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined with Stereotactic Radiation in Patients with Brain Metastases,” (ADORATION), requires patients to take two oral doses of azeliragon per day for six days prior to radiation therapy. Following radiation, patients take one oral dose a day for at least eight weeks but may continue the medication longer if well-tolerated. Patients are regularly assessed and visit the Institute for routine surveillance throughout the study.

About Miami Cancer Institute

Miami Cancer Institute brings to South Florida access to personalized clinical treatments and comprehensive support services delivered with unparalleled compassion. No other cancer program in the region has the combination of cancer-fighting expertise and advanced technology—including the first proton therapy center in South Florida, Latin America and the Caribbean, and one of the only radiation oncology programs in the world with each of the newest radiation therapies in one place—to diagnose and deliver precise cancer treatments that achieve the best outcomes and improve the lives of cancer patients. The Institute offers an impressive roster of established community oncologists and renowned experts, clinical researchers and genomic scientists recruited from the nation’s top cancer centers. Selected as Florida’s only member of the Memorial Sloan Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of a meaningful clinical collaboration that affords patients in South Florida access to innovative treatments and ensures that the standards of care developed by their multidisciplinary disease management teams match those at MSK. For more information, please visit https://cancer.baptisthealth.net/miami-cancer-institute.

Miami Cancer Institute is part of Baptist Health Cancer Care, the largest cancer program in South Florida, with locations from the Florida Keys to the Palm Beaches.

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