MC240703 Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 202
- 试验地点
- 3
- 主要终点
- 4-month progression-free survival (PFS) rate (Subprotocol 1)
研究概览
简要总结
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.
详细描述
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 remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bevacizumab (Drug)
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.
干预措施: Imipramine (Drug)
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.
干预措施: Propranolol (Drug)
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.
干预措施: Chemotherapy (Drug)
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Internet-Based Intervention (Other)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
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.
干预措施: Neurologic Examination (Procedure)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Surveillance (Behavioral)
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
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.
干预措施: Neurologic Examination (Procedure)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
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.
干预措施: Neurologic Examination (Procedure)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Imipramine (Drug)
结局指标
主要结局
4-month progression-free survival (PFS) rate (Subprotocol 1)
时间窗: 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.
Feasibility - completion of study visits
时间窗: 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.
次要结局
- Objective response rate(Up to 3 years)
- Incidence of adverse events(Up to 3 years)
- Safety of the overall platform(Up to 3 years)
- Overall survival (OS) from initiation of study treatment (Subprotocol 1)(Up to 3 years)
- Objective response rate (ORR) (Subprotocol 1)(Up to 3 years)
- Incidence of adverse events (Subprotocol 1)(Up to 3 years)
- 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)
- Incidence of adverse events(Up to 3 years)
- Safety of the overall platform(Up to 3 years)