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

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• Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
• SUBSTUDY 1: Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings

Egyéb

• Pregnant or nursing, imprisoned, or lacking capacity for understanding
• SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding

• 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