CNS Tumors With Latent Residual Disease To Guide Individualized Therapies
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: 23-008241
NCT ID: NCT07025226
Sponsor Protocol Number: MC230715
About this study
The purpsoe of this study is to determine the feasibility of transitioning patients with brain tumors from one candidate senolytic therapy to the next in a response-based adaptive approach.
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
Disease criteria
Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stable disease based on RANO criteria
Must have IDH-mutant OR MGMT-methylated glioma
Patients with any radiographic evidence of residual disease are eligible
ECOG of 0, 1, or 2, and Karnofsky Performance Status >50
The following laboratory values obtained ≤15 days prior to registration to ensure adequate bone marrow and liver function.
Hemoglobin ≥9.0 g/dL
Absolute neutrophil count (ANC) ≥1500/mm
Platelet count ≥100,000/mm3 (without transfusion ≤7 days preceding lab assessment)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN (or ≤5 x ULN for patients with liver involvement)
Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula
Average QTc≤450 ms on triplicate 12 lead ECG ≤29 days prior to registration. NOTE: QTc intervals will be corrected using Fridericia’s formula (Fridericia 1920)
Negative serum pregnancy test is required for persons of childbearing potential ≤8 days prior to registration.
Presence of an implanted cranial CSF access device, such as Ommaya reservoir or ventriculoperitoneal shunt.
Willingness to provide blood and CSF samples for research (see Sections 6.0 and 14.0).
Co-enrollment on the Neuro-Oncology biorepository (IRB12-003458) for collection of research blood and CSF samples.
Provide written informed consent.
Willingness to return to Mayo Clinic for follow-up
Exclusion Criteria:
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Patients who are not appropriate medical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, or duodenal/jejunal resection
Patients with known hypersensitivity or allergy to all of the study drugs on the protocol (known hypersensitivity or allergy to one drug does not preclude participation in this protocol).
Inability to undergo MRI scans
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 06/07/2024. 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 Terence Burns, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available