A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial

NCT07074756 | Recruiting DMC

• 2 other identifiers: MC24070324-009234
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Feasibility - completion of study visits

  Feasibility will be assessed by the number of study visits completed vs. not. Will consider this to be feasible in this patient population if the true compliance rate is at least 60%. Compliance here is defined as completion of at least 4 disease assessment timepoints in the first 6 months on study (i.e. 26 ± 2 weeks). These assessment timepoints will include the baseline assessment and can include assessments after 2 cycles of therapy, after 4 cycles of therapy, after 6 cycles of therapy, dependent on the treatment-specific schedules.

  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)

  Defined as the number of patients who are alive and progression-free at least 4 months after beginning study therapy. A point estimate will be generated for 4-month PFS rate.

  Up to 4 months after beginning study therapy

Secondary Outcomes (10)

• Acceptance of and satisfaction of patients with the remote monitoring

  Up to 3 years

• Adherence to study therapeutics

  Up to 3 years

• Feasibility of remote systemic therapy assessments

  Up to 3 years

• Progression free survival (PFS) for each therapeutic treatment diagnosed and recurrent glioma

  At 6 months

• Objective response rate

  Up to 3 years

Study Arms (3)

GHoST Master Protocol (remote chemotherapy management)

EXPERIMENTAL

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.

Drug: Chemotherapy; Procedure: Computed Tomography; Other: Internet-Based Intervention; Procedure: Magnetic Resonance Imaging; Procedure: Neurologic Examination; Other: Questionnaire Administration; Behavioral: Surveillance

Subprotocol 1 Group A (propranolol, bevacizumab)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Neurologic Examination; Other: Questionnaire Administration; Drug: Propranolol; Drug: Imipramine

Subprotocol 1 Group B (imipramine, bevacizumab)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Neurologic Examination; Other: Questionnaire Administration; Drug: Imipramine; Drug: Bevacizumab

Interventions

Surveillance BEHAVIORAL

Undergo surveillance

Also known as: Epidemiology / Surveillance

GHoST Master Protocol (remote chemotherapy management)

Chemotherapy DRUG

Receive standard of care chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

GHoST Master Protocol (remote chemotherapy management)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

GHoST Master Protocol (remote chemotherapy management); Subprotocol 1 Group A (propranolol, bevacizumab); Subprotocol 1 Group B (imipramine, bevacizumab)

Neurologic Examination PROCEDURE

Ancillary studies

Also known as: Nervous System Examination, Neurological Assessment, neurological exam, Neurological Examination, NVEXAM

GHoST Master Protocol (remote chemotherapy management); Subprotocol 1 Group A (propranolol, bevacizumab); Subprotocol 1 Group B (imipramine, bevacizumab)

Questionnaire Administration OTHER

Ancillary studies

GHoST Master Protocol (remote chemotherapy management); Subprotocol 1 Group A (propranolol, bevacizumab); Subprotocol 1 Group B (imipramine, bevacizumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

GHoST Master Protocol (remote chemotherapy management); Subprotocol 1 Group A (propranolol, bevacizumab); Subprotocol 1 Group B (imipramine, bevacizumab)

Internet-Based Intervention OTHER

Receive access to the remote chemotherapy management and patient monitoring platform

GHoST Master Protocol (remote chemotherapy management)

Propranolol DRUG

Given PO

Also known as: 1-((1-Methylethyl)amino)-3-(1-naphthalenyloxy)-2-propanol, 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol, 525-66-6

Subprotocol 1 Group A (propranolol, bevacizumab)

Imipramine DRUG

Given PO

Also known as: 50-49-7, 5H-Dibenz(b,f)azepine, 5-(3-(dimethylamino)propyl)-10,11-dihydro-

Subprotocol 1 Group A (propranolol, bevacizumab); Subprotocol 1 Group B (imipramine, bevacizumab)

Bevacizumab DRUG

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avegra, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Equidacent, CTP16, CT P16, CT-P16, FKB 238, FKB238, FKB-238, HD204, IBI 305, IBI-305, IBI305, Jobevne, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev, SCT501, SIBP 04, SIBP-04, SIBP04, MB 02, MB-02, MB02

Subprotocol 1 Group B (imipramine, bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

Drug Therapy; Magnetic Resonance Spectroscopy; Propranolol; Imipramine; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ugur T. Sener, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

CONTACT

507-293-6386

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

US (2)