MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
Mayo Clinic
Summary
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.
Description
PRIMARY OBJECTIVES: I. Determine the feasibility of the remote chemotherapy management and patient monitoring platform glioma home-based sequential therapy (GHoST) protocol among patients with glioma undergoing systemic therapy. II. Determine the efficacy, as measured by the 4-month progression free survival (PFS) rate, of propranolol and imipramine, when used in combination with bevacizumab for the treatment of recurrent glioblastoma. (Subprotocol 1: PRIME) SECONDARY OBJECTIVES: I. Evaluate compliance, adherence, and feasibility in terms of the adherence to systemic therapy monitored remo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months. * NOTE: Patient may be enrolled following completion of surgery and/or radiation therapy for newly diagnosed or recurrent tumor. * NOTE: Any number of prior recurrences is permitted * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60 * Expected survival ≥ 6 months in the opinion of treatment team * Willing and able to adhere with the protocol for the duration of the stu…
Interventions
- DrugChemotherapy
Receive standard of care chemotherapy
- ProcedureComputed Tomography
Undergo CT
- OtherInternet-Based Intervention
Receive access to the remote chemotherapy management and patient monitoring platform
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureNeurologic Examination
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- BehavioralSurveillance
Locations (2)
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in RochesterRochester, Minnesota