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New treatment option for Glioma
Official title Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease
ClinicalTrials.gov ID: NCT07025226
What this study is testing
What is Dasatinib?
Dasatinib is an investigational medicine, being studied as a potential treatment for glioma.
Also referred to as BMS 354825, BMS-354825.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous tumor lysate particle only (TLPO) vaccine work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Treatment Arm (Regimens 1-8):
- Age ≥ 18 years
- Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stable disease based on Response Assessment in Neuro-Oncology (RANO)...
- Must have IDH-mutant OR MGMT-methylated glioma
- NOTE: Patients with any radiographic evidence of residual disease are eligible
You likely can't join if
- Treatment Arm (Regimens 1-8):
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
- Patients who are not appropriate medical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of...
See the full eligibility criteria
- Treatment Arm (Regimens 1-8):
- Age ≥ 18 years
- Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stable disease based on Response Assessment in Neuro-Oncology (RANO) criteria
- Must have IDH-mutant OR MGMT-methylated glioma
- NOTE: Patients with any radiographic evidence of residual disease are eligible
- Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2, and Karnofsky performance status \>= 50
- Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (≤ 15 days prior to registration)
- Platelet count ≥ 100,000/mm\^3 (without transfusion ≤ 7 days preceding lab assessment) (≤ 15 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN for patients with liver involvement) (≤ 15 days prior to registration)
- Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (≤ 15 days prior to registration)
- Average corrected QT interval (QTc) ≤ 450 ms on triplicate 12 lead electrocardiogram (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
- Co-enrollment on the neuro-oncology biorepository [institutional review board (IRB) 12-003458] for collection of research blood and CSF samples
- Provide written informed consent
- Willingness to return to Mayo Clinic for follow-up
- Monitoring Arm (Regimen 1 only):
- Age ≥ 18 years
- Prior diagnosis of a glioma
- Negative serum pregnancy test is required for persons of childbearing potential ≤ 8 days prior to registration
- Co-enrollment on the neuro-oncology biorepository [institutional review board (IRB) 12-003458] for collection of research blood and CSF samples
- Provide written informed consent
- Willingness to return to Mayo Clinic for follow-up
- Treatment Arm (Regimens 1-8):
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
- 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
- NOTE: An exception can be granted for such patients if no oral medications are planned (i.e., patient will receive only IV or intradermal agents)
- 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: These patients may be enrolled in the Monitoring Arm Exclusion Criteria - Monitoring Arm (Regimen 1 only):
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
- Current or past medical history or uncontrolled concurrent illness which limits safety or compliance with study proceedings
- Known hypersensitivity or allergy to radioactive tracers
- Inability to undergo clinical imaging
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.