GliomaNCT07074756
A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma, GHoST Trial
A study testing Chemotherapy, Computed Tomography and Internet-Based Intervention in people with Glioma and Recurrent Glioma, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Recurrent Glioma, Recurrent Glioblastoma
- What is being tested?
- Chemotherapy, Computed Tomography and Internet-Based Intervention
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Center Clinical Trials contact
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cancer Center Clinical Trials, 507-293-6386
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cancer Center Clinical Trials, 507-293-6386
About this study
Official title: MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- Evaluate compliance, adherence, and feasibility in terms of the adherence to systemic therapy monitored remotely.
II. Determine progression free survival (PFS) for each therapeutic evaluated for newly diagnosed or recurrent glioma, stratified by tumor type.
III. Determine objective response rate (ORR) for each therapeutic evaluated for newly diagnosed or recurrent glioma, stratified by tumor type.
IV. Assess the safety and tolerability of remote chemotherapy management and patient monitoring among patients with glioma undergoing systemic therapy.
- Determine overall survival (OS) for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME) VI. Determine objective response rate (ORR) for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME) VII. Assess the safety and tolerability for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME)
EXPLORATORY OBJECTIVES:
- Assess the acceptance or satisfaction of patients with the remote monitoring in this trial and how these may differ between newly diagnosed and recurrent glioma.
II. Investigate PFS based on therapeutic sequence administered. III. Explore potential differences in compliance, adherence, and satisfaction measures and how they may correspond to health disparities and social determinants of health.
IV. Compare access to neuro-oncology care at Mayo Clinic among patients with low socioeconomic status assessed based on the Mayo Clinic Housing-Based Socioeconomic Status (HOUSES) Index during the two years following study activation compared to historical utilization data.
- Compare access to neuro-oncology care at Mayo Clinic among patients with increased distance from academic centers assessed by geospatial index during the two years following study activation compared to historical utilization data.
OUTLINE:
GHoST MASTER PROTOCOL: 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 magnetic resonance imaging (MRI) or computed tomography (CT) throughout the study.
SUBPROTOCOL 1 - PRIME: Patients with recurrent glioblastoma receiving bevacizumab on the GHoST Master Protocol as assigned by their treating physician are randomized to 1 of 2 groups.
GROUP A: Patients receive propranolol orally (PO) twice daily (BID) and standard of care (SOC) bevacizumab intravenously (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.
GROUP B: Patients receive imipramine PO once daily (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.
- Conditions
- Glioma, Recurrent Glioma, Recurrent Glioblastoma
- Being tested
- Chemotherapy, Computed Tomography, Internet-Based Intervention, Magnetic Resonance Imaging, Neurologic Examination
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Receive standard of care chemotherapy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Internet-Based InterventionOther
Receive access to the remote chemotherapy management and patient monitoring platform
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Neurologic ExaminationProcedure or surgery
Also called Nervous System Examination, Neurological Assessment, neurological exam, Neurological Examination
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
SurveillanceBehavioural
Also called Epidemiology / Surveillance
Undergo surveillance
PropranololDrug
Also called 1-((1-Methylethyl)amino)-3-(1-naphthalenyloxy)-2-propanol, 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol, 525-66-6
Given PO
ImipramineDrug
Also called 50-49-7, 5H-Dibenz(b,f)azepine, 5-(3-(dimethylamino)propyl)-10,11-dihydro-
Given PO
BevacizumabDrug
Also called ABP 215, ABP-215, ABP215, Alymsys
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Neurologic Examination; Other: Questionnaire Administration; Drug: Imipramine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 4 months after beginning study therapy
Secondary outcomes (10)
Acceptance of and satisfaction of patients with the remote monitoring
Will be assessed with an electronic Assessment of Acceptance and Satisfaction survey sent to participants at study assessment timepoints. The satisfaction survey consists of a single question answered on a 5-point scale: very positive, somewhat positive, neutral, somewhat negative, very negative.
Measured: Up to 3 years
Adherence to study therapeutics
Will be assessed through remote monitoring application. Here, adherence is defined as taking at least 80% of the prescribed doses, for all therapies other than lomustine. For lomustine, adherence is defined as receiving all prescribed infusions.
Measured: Up to 3 years
Feasibility of remote systemic therapy assessments
Will be assessed through completion of visits as scheduled, where laboratory and imaging assessed for the visits are scheduled and completed prior to telehealth visits. Feasibility will be defined as having necessary pre-visit testing completed and delivered for clinician review prior to the visit as well as completion of the visit at the intended scheduled time for 60% of the visits.
Measured: Up to 3 years
Progression free survival (PFS) for each therapeutic treatment diagnosed and recurrent glioma
Will be assessed for each treatment evaluated. PFS is defined as the time from enrollment to disease progression or death, whichever occurs first.
Measured: At 6 months
Objective response rate
Objective response rate for each therapeutic for newly diagnosed and recurrent glioma will be assessed.
Measured: Up to 3 years
Incidence of adverse events
Will be assessed by type along with grade and perceived attribution to study agent based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 3 years
Safety of the overall platform
Will be assessed by acute care utilization days (defined as emergency department evaluations and inpatient days) for participants on the platform compared to historical clinical data.
Measured: Up to 3 years
Overall survival (OS) from initiation of study treatment (Subprotocol 1)
Defined as the time from initiation of study treatment and survival time from initial diagnosis.
Measured: Up to 3 years
Objective response rate (ORR) (Subprotocol 1)
Defined as the time from initiation of study treatment and survival time from initial diagnosis. Will be assessed per Response Assessment in Neuro-Oncology (RANO) Criteria 2.0
Measured: Up to 3 years
Incidence of adverse events (Subprotocol 1)
Will be assessed by type along with grade and perceived attribution to study agent based on NCI CTCAE version 5.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start12 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugur T. Sener, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074756
- Sponsor's protocol ID
- MC240703
- Other IDs
- 24-009234
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
- ClinicalTrials.gov ID
- NCT07074756
- Acronym / sponsor ID
- MC240703
- Conditions
- Glioma, Recurrent Glioma, Recurrent Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- Evaluate compliance, adherence, and feasibility in terms of the adherence to systemic therapy monitored remotely.
II. Determine progression free survival (PFS) for each therapeutic evaluated for newly diagnosed or recurrent glioma, stratified by tumor type.
III. Determine objective response rate (ORR) for each therapeutic evaluated for newly diagnosed or recurrent glioma, stratified by tumor type.
IV. Assess the safety and tolerability of remote chemotherapy management and patient monitoring among patients with glioma undergoing systemic therapy.
- Determine overall survival (OS) for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME) VI. Determine objective response rate (ORR) for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME) VII. Assess the safety and tolerability for each therapeutic evaluated for recurrent glioblastoma when used in combination with bevacizumab. (Subprotocol 1: PRIME)
EXPLORATORY OBJECTIVES:
- Assess the acceptance or satisfaction of patients with the remote monitoring in this trial and how these may differ between newly diagnosed and recurrent glioma.
II. Investigate PFS based on therapeutic sequence administered. III. Explore potential differences in compliance, adherence, and satisfaction measures and how they may correspond to health disparities and social determinants of health.
IV. Compare access to neuro-oncology care at Mayo Clinic among patients with low socioeconomic status assessed based on the Mayo Clinic Housing-Based Socioeconomic Status (HOUSES) Index during the two years following study activation compared to historical utilization data.
- Compare access to neuro-oncology care at Mayo Clinic among patients with increased distance from academic centers assessed by geospatial index during the two years following study activation compared to historical utilization data.
OUTLINE:
GHoST MASTER PROTOCOL: 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 magnetic resonance imaging (MRI) or computed tomography (CT) throughout the study.
SUBPROTOCOL 1 - PRIME: Patients with recurrent glioblastoma receiving bevacizumab on the GHoST Master Protocol as assigned by their treating physician are randomized to 1 of 2 groups.
GROUP A: Patients receive propranolol orally (PO) twice daily (BID) and standard of care (SOC) bevacizumab intravenously (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.
GROUP B: Patients receive imipramine PO once daily (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GHoST Master Protocol (remote chemotherapy management) | Experimental | Drug: Chemotherapy, Procedure: Computed Tomography, Other: Internet-Based Intervention, Procedure: Magnetic Resonance Imaging, Procedure: Neurologic Examination, Other: Questionnaire Administration, Behavioral: SurveillancePatients 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. |
| Subprotocol 1 Group A (propranolol, bevacizumab) | Experimental | Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Neurologic Examination, Other: Questionnaire Administration, Drug: Propranolol, Drug: ImipraminePatients 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. |
| Subprotocol 1 Group B (imipramine, bevacizumab) | Experimental | Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Neurologic Examination, Other: Questionnaire Administration, Drug: Imipramine, Drug: BevacizumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years
- Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralReceive standard of care chemotherapy | Drug | GHoST Master Protocol (remote chemotherapy management) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | GHoST Master Protocol (remote chemotherapy management), Subprotocol 1 Group A (propranolol, bevacizumab), Subprotocol 1 Group B (imipramine, bevacizumab) |
| Internet-Based InterventionReceive access to the remote chemotherapy management and patient monitoring platform | Other | GHoST Master Protocol (remote chemotherapy management) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | GHoST Master Protocol (remote chemotherapy management), Subprotocol 1 Group A (propranolol, bevacizumab), Subprotocol 1 Group B (imipramine, bevacizumab) |
| Neurologic ExaminationAlso: Nervous System Examination, Neurological Assessment, neurological exam, Neurological ExaminationAncillary studies | Procedure or surgery | GHoST Master Protocol (remote chemotherapy management), Subprotocol 1 Group A (propranolol, bevacizumab), Subprotocol 1 Group B (imipramine, bevacizumab) |
| Questionnaire AdministrationAncillary studies | Other | GHoST Master Protocol (remote chemotherapy management), Subprotocol 1 Group A (propranolol, bevacizumab), Subprotocol 1 Group B (imipramine, bevacizumab) |
| SurveillanceAlso: Epidemiology / SurveillanceUndergo surveillance | Behavioural | GHoST Master Protocol (remote chemotherapy management) |
| PropranololAlso: 1-((1-Methylethyl)amino)-3-(1-naphthalenyloxy)-2-propanol, 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol, 525-66-6Given PO | Drug | Subprotocol 1 Group A (propranolol, bevacizumab) |
| ImipramineAlso: 50-49-7, 5H-Dibenz(b,f)azepine, 5-(3-(dimethylamino)propyl)-10,11-dihydro-Given PO | Drug | Subprotocol 1 Group A (propranolol, bevacizumab), Subprotocol 1 Group B (imipramine, bevacizumab) |
| BevacizumabAlso: ABP 215, ABP-215, ABP215, AlymsysGiven IV | Drug | Subprotocol 1 Group B (imipramine, bevacizumab) |
Primary outcome
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)
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.
4-month progression-free survival (PFS) rate (Subprotocol 1)
Time frame: Up to 4 months after beginning study therapy
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.
10 secondary outcomes
Acceptance of and satisfaction of patients with the remote monitoring
Time frame: Up to 3 years
Adherence to study therapeutics
Time frame: Up to 3 years
Feasibility of remote systemic therapy assessments
Time frame: Up to 3 years
Progression free survival (PFS) for each therapeutic treatment diagnosed and recurrent glioma
Time frame: At 6 months
Objective response rate
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 3 years
Safety of the overall platform
Time frame: Up to 3 years
Overall survival (OS) from initiation of study treatment (Subprotocol 1)
Time frame: Up to 3 years
Objective response rate (ORR) (Subprotocol 1)
Time frame: Up to 3 years
Incidence of adverse events (Subprotocol 1)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center Clinical Trials contact
Ugur T. Sener, MD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy, Computed Tomography and Internet-Based Intervention in people with Glioma and Recurrent Glioma, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.