Clinical trial for Progressive Glioblastoma
Official title Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07076472
What this study is testing
What is Aminolevulinic Acid Intravenous Formulation SONALA-001?
An investigational intravenous drug being studied as a potential treatment for progressive or recurrent glioblastoma. It is designed to be taken up by tumor cells and converted into a light‑sensitive compound that can be activated by focused ultrasound to help kill cancer cells.
Also referred to as ALA Intravenous Formulation SONALA-001, SONALA 001, SONALA-001, SONALA001.
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 study is testing whether a sound-wave treatment works well. It also checks how safe it is and finds the best amount to use.
- Who it's for
- You may be able to join if you have brain cancer that is growing or has returned.
- What's involved
- You would get a drug that sticks to the tumor. Then, a machine uses sound waves to activate the drug and kill the tumor cells.
- Time commitment
- The study involves visits to get the treatment and check on your health.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
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
- Age ≥ 18 years
- Diagnosis of recurrent or progressive glioblastoma (as defined in 2021 World Health Organization [WHO] Classification of Tumors of the Central...
- 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)
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- 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)
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.