A Study Of Home-Based Therapy For Glioma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-009234
- Jacksonville, Florida: 24-009234
NCT ID: NCT07074756
Sponsor Protocol Number: MC240703
About this study
The purpose of this study is to determine the feasibility of the remote chemotherapy management and patient monitoring platform GHoST Protocol among patients with glioma undergoing systemic therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Age ≥18 years.
Diagnosis of glioma and intention to treat with systemic therapy. 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.
Sufficient washout from prior systemic therapy at the time of registration:
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.
The following laboratory values obtained ≤30 days prior to registration:
White blood cell (WBC) count ≥ 3,000
Absolute neutrophil count (ANC) ≥ 1,500
Platelet count ≥ 100,000 at baseline prior to systemic therapy initiation
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN (≤5 x ULN for patients with baseline liver disease).
Negative pregnancy test ≤8 days prior to registration for persons of childbearing potential only
Provide written informed consent
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.
Currently on tumor-directed systemic therapy.
Any of the following cardiac criteria:
Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE Grade 1) using Fredericia’s QT correction formula
History of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Use of concomitant medications that prolong the QT/QTc interval
History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 03/10/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Ugur Sener, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Wendy Sherman, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available