Jacki Garcia and Kristin Hendrickson on Navigating Patients Through Phase 0 Trials

In this episode of The Vitals, Oncology Nursing News® spoke with Jacki Garcia, RN, BSN, CNRN; and Kristin Hendrickson, BA, RN, to discuss phase 0 trials, also known as window-of-opportunity trials, in neuro-oncology.

Phase 0 trials are designed to identify new drugs capable of slowing tumor progression in patients who face poor prognoses.¹ Patients who enroll in a phase 0 trial receive a subtherapeutic dose of an agent prior to undergoing surgery. When the tissue is resected, investigators determine whether the agent penetrated the blood-brain barrier and whether the agent had the anticipated effect. If the agent demonstrates therapeutic effect, patients may be able to continue the treatment going forward. According to Garcia, who is a nurse navigator, and Hendrickson, who is a research program manager, both with the Ivy Brain Tumor Center at Barrow Neurological Institute, phase 0 trials are important because they offer patients with brain tumors another potential treatment option.

The nurses note that despite the prevalence of malignant brain tumors with poor prognoses, such as glioblastoma,² they are on the frontline of a lot of exciting research efforts, and are optimistic about the trajectory of the treatment paradigm.

“There are long-term survivors out there,” Garcia said. “I have seen them. So, for [individuals] who have a view of this disease is that this as a terminal diagnosis, just know that there is some element of hope out there. “

Episode Highlights

“Once it has been determined that the patient is a surgical candidate and is being recommended for a phase 0 trial, then the research nurse team has discussions with the patient where we talk about the requirements for the clinical trial. We make sure that they can consent [to] the clinical trial, [that] they meet the inclusion criteria for the trial and do not meet any of the exclusion criteria. We are looking at the whole picture.” Time stamp (TS) 2:44

“There are different courses for each patient, but we want to make sure that they are exploring every avenue possible [to] treat [patients with] this diagnosis.” TS 11:47

“As an institute, [and] a clinical trials program, we really want to reach underserved populations who may have no knowledge of clinical trials. It is really important that those populations know that there are multiple treatment options to consider so they can make the best-informed decision for themselves and their families.” TS 11:56

Oncology Nursing News Articles:

• Vorasidenib Demonstrates PFS Benefit in IDH-Mutant Low-Grade Glioma
• Investigational CAR T Product GD2-CART01 Displays Safety and Efficacy in Pediatric Neuroblastoma
• Chemoimmunotherapy Yields Promising Objective Responses in Patients With High-Risk Neuroblastoma
• Reirradiation May Play a Role in Recurrent Glioblastoma, Although Optimal Treatment Remains Controversial
• Clinical Trials Continue to Propel Field of Oncology with Nurses on The Frontline

Video Interviews:

• Manmeet Ahulwalia on Targeting the Blood-Brain Barrier With Novel Immunotherapies and Precision Oncology
• Kathryn Beal on Aftercare for Patients with Primary Brain Tumors
• Anita Mahajan on the Nurse’s Role When Treating Patients with Brain Cancer

The Vitals Podcast:

• A Look Back at 2022 FDA Approvals in Oncology
• Focus on ‘A Different Kind of Hope’ in Cancer

References

1. Vogelbaum MA, Krivosheya D, Borghei-Razavi H, et al. Phase 0 and window of opportunity clinical trial design in neuro-oncology: a RANO review. Neuro Oncol. 2020;22(11):1568-1579. doi:10.1093/neuonc/noaa149
2. Siegel, RL, Miller, KD, Wagle, NS, Jemal, A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17- 48. doi:10.3322/caac.21763