Is NCT07025226 recruiting in Rochester, MN?

Yes, NCT07025226 is currently recruiting participants at its Rochester, MN location. This glioma clinical trial is actively enrolling qualified participants.

How do I join the glioma clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Glioma Clinical Trial in Rochester, MN

About This Glioma Study in Rochester

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. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They have antioxidant and anti-inflammatory properties and help remove senescent cells, older or damaged cells that have stopped dividing but don't die off as they should and build up in tissues over time. Senescent cells may cause inflammation or damage to nearby healthy cells. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. LMP744 works by interfering with a protein that tumor cells use to copy and repair their DNA. By blocking this repair process, the drug causes DNA damage so that tumor cells cannot survive. The autologous TLPO vaccine is made using material from a patient's own tumor. It delivers the tumor material to immune cells so they can learn to recognize and attack the cancer. Giving medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous TLPO vaccine may be safe, tolerable and/or effective in treating patients with previously treated glioma with residual disease.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion 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 Inclusion Criteria - 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

Exclusion Criteria

- 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07025226) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Glioma Treatment Options in Rochester, MN

If you're searching for glioma treatment options in Rochester, MN, this clinical trial (NCT07025226) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all glioma clinical trials near you to find additional studies recruiting in your area.

Glioma Clinical Trial in Rochester, MN

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