BridgeMD
New treatment option 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?
Aminolevulinic Acid Intravenous Formulation SONALA-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for progressive glioblastoma.
Also referred to as ALA Intravenous Formulation SONALA-001, SONALA 001.
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, 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.
- 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
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the...
- 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
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. 2021) for which resection is not...
- 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)
- 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...
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 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?
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.