Revolutionary clinical trial fast tracks trials for patients with brain tumor

the ONA take:

A new type of early phase clinical trial was recently introduced by the FDA, and is now being used to fast track potential drugs for the treatment of brain cancer.

Called Phase 0 trials, these early-phase clinical trials can shorten the evaluation of a drug from an average of 5 years to only 6 months at a much lower cost. Phase 0 trials occur outside the three lengthy phases of a standard clinical trial used to evaluate drug safety, effectiveness, side effects, and dosage.

In each single-patient trial, brain tumor experts at Barrow Neurological Institute at Dignity Health St. Joseph’s Hospital and Medical Center administer a drug already proven effective in other types of cancer to a participant with brain cancer. Barrow neurosurgeons remove the brain tumor within hours, and within weeks, determine whether the drug penetrated the blood-brain barrier to reach the tumor.

If the drug reached the tumor and is effective, it moves into a phase 2 clinical trial for patients. If it does not, the patient has the option to enter another study.

Barrow is conducting its phase 0 trials in partnership with The Ben & Catherine Ivy Foundation, the Translational Genomics Research Institute (TGen) and the Barbara Ann Karmanos Cancer Institute.