Recruiting

Digital Treatment Platform

Sponsor:

Mayo Clinic

Code:

NCT07074756

Conditions

Glioma

Recurrent Glioma

Recurrent Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Computed Tomography

Internet-Based Intervention

Magnetic Resonance Imaging

Neurologic Examination

Study Details

Brief 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.

Conditions

Glioma

Recurrent Glioma

Recurrent Glioblastoma

Study ID

NCT07074756

Start date

Sep 12, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 study including undergoing treatment, and attending scheduled visits, and examinations
  • Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only

  • Exception: Not required if patient is already on treatment. May be obtained prior to next treatment as needed per clinical care
  • Provide written informed consent
  • Ability to complete assessments and questionnaires by themselves or with assistance
  • SUBSTUDY 1: Enrolled in GHoST Master Protocol per eligibility criteria of the master study and clinically appropriate to proceed with bevacizumab treatment at the discretion of the treating physician
  • SUBSTUDY 1: Diagnosis of recurrent glioblastoma and intention to treat with bevacizumab

  • NOTE: Any number of prior recurrences is permitted
  • NOTE: Prior limited use of bevacizumab for radiation necrosis/treatment related edema is permitted. Prior use should not exceed four infusions with the last dose administered ≥ 4 weeks prior to enrollment in this substudy
  • SUBSTUDY 1: Willing and able to adhere to the substudy for the duration of the substudy including undergoing treatment, and attending scheduled visits, and examinations
  • SUBSTUDY 1: Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
  • SUBSTUDY 1: Provide written informed consent
  • SUBSTUDY 1: Ability to complete assessments and questionnaires by themselves or with assistance

Exclusion Criteria:

  • Pregnant or nursing, imprisoned, or lacking capacity for understanding
  • Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
  • SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding
  • SUBSTUDY 1: Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GHoST Master Protocol (remote chemotherapy management)

Patients receive access to the remote chemotherapy management and patient monitoring platform to watch educational videos, report when medication is taken or missed, and report any symptoms related to cancer or medication side effects on study. Patients also receive standard of care chemotherapy as assigned by their treating physician as part of the platform on study. Upon completion of standard of care chemotherapy, if there is no disease progression, patients transition to surveillance for up to 1 year. Patients who experience disease progression during treatment or surveillance may rejoin the platform and/or be assigned by their treating physician to a different chemotherapy agent as part of the platform. Patients also undergo MRI or CT throughout the study.

experimental: Subprotocol 1 Group A (propranolol, bevacizumab)

Patients receive propranolol PO BID and SOC bevacizumab IV every 3 weeks of each cycle. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the study.

experimental: Subprotocol 1 Group B (imipramine, bevacizumab)

Patients receive imipramine PO QD and SOC bevacizumab IV every 3 weeks of each cycle. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the study.

Interventions

Chemotherapy

Receive standard of care chemotherapy

Computed Tomography

Undergo CT

Internet-Based Intervention

Receive access to the remote chemotherapy management and patient monitoring platform

Magnetic Resonance Imaging

Undergo MRI

Neurologic Examination

Ancillary studies

Questionnaire Administration

Ancillary studies

Surveillance

Undergo surveillance

Propranolol

Given PO

Imipramine

Given PO

Bevacizumab

Given IV

Primary outcome measure

  • Feasibility - completion of study visits [ Time Frame: At baseline and the set of study-specific visits through 6 months (i.e., 26 weeks ± 2 weeks) ]
  • 4-month progression-free survival (PFS) rate (Subprotocol 1) [ Time Frame: Up to 4 months after beginning study therapy ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Principal Investigator:

Wendy J. Sherman, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Principal Investigator:

Ugur T. Sener, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-10.