Is NCT07076472 recruiting in Rochester, MN?

Yes, NCT07076472 is currently recruiting participants at its Rochester, MN location. This progressive glioblastoma clinical trial is actively enrolling qualified participants.

How do I join the progressive glioblastoma 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.

Progressive Glioblastoma Clinical Trial in Rochester, MN

About This Progressive Glioblastoma Study in Rochester

This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Diagnosis of recurrent or progressive glioblastoma (as defined in 2021 World Health Organization \[WHO\] Classification of Tumors of the Central Nervous System; Louis, Perry, et al. 2021) for which resection is not indicated as assessed by the study physician

Radiographic evidence of disease which may be measurable or non-measurable

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Previous treatment with radiotherapy (RT)

Have a life expectancy of ≥ 12 weeks

Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)

Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)

Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)

Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)

Albumin ≥ 3 g/dL (obtained ≤ 15 days prior to registration)

Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration)

Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration)

Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)

Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only

Provide written informed consent

Willing to participate in the neuro-oncology biorepository \[Institutional Review Board (IRB) 12-003458, principal investigator (PI): Jann Sarkaria, MD, PhD\] for collecting and archiving biospecimens samples on neuro-oncology patients

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:

Pregnant persons

Nursing persons

Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT

Three or more prior systemic treatments for recurrent or progressing disease

Diagnosis of porphyria, or hypersensitivity to porphyrins

Failure to recover to grade 1 or baseline from any adverse events (AEs) (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) related to prior anticancer therapy

EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3)

Known history of the following conditions:

Allergy to gadolinium contrast agents

Patients known to be HIV positive and currently receiving antiretroviral therapy

NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

Inability to undergo MRI scans

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection

Patients with platelet count \< 100

Symptomatic congestive heart failure

Unstable angina pectoris

Cardiac arrhythmia

Or psychiatric illness/social situations that would limit compliance with study requirements

History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

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 (NCT07076472) 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.

Progressive Glioblastoma Treatment Options in Rochester, MN

If you're searching for progressive glioblastoma treatment options in Rochester, MN, this clinical trial (NCT07076472) 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 progressive glioblastoma 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 progressive glioblastoma clinical trials near you to find additional studies recruiting in your area.

Progressive Glioblastoma Clinical Trial in Rochester, MN

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IRB Approved

No-Cost Care

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