- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362409
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Alpheus Medical
- Phone Number: (612) 234-4009
- Email: info@alpheusmedical.com
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine in St.Louis
-
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New York
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Amherst, New York, United States, 14226
- Dent Neurosciences Research Center
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Lake Success, New York, United States, 11042
- Northwell
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria
- Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
- ≥ 18 years of age
- WHO performance status of ≤ 2 at screening
Part A: Previous histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Eligible histologies include (according to WHO classification 2021):
- Astrocytoma, WHO grade 3 and 4 (including subtypes)
- Oligodendroglioma WHO grade 3 (including subtypes)
Parts B and C: Previous histopathologically confirmed diagnosis of glioblastoma and radiographic evidence of recurrence after prior therapy with radiotherapy. While Part A may include patients with any type of HGG and any number of recurrences, Parts B and C are restricted to patients with glioblastoma experiencing first recurrence.
- Unifocal or multifocal tumor confined to the supratentorial compartment
Interval since last anti-cancer therapy relative to first 5-ALA treatment, as detailed below
- End of radiotherapy >12 weeks (including skin-directed radiation for skin cancer),
- Last cytotoxic chemotherapy (4 weeks, if prior nitrosureas 6 weeks).
- Last biological therapy, i. If bevacizumab ≥ 6 weeks ii. If other monoclonal antibody, e.g., immune checkpoint inhibitor > 3 weeks iii. If tyrosine kinase inhibitor or other small molecule > 2 weeks
- Any other investigational agent(s) ≥ 30 days or 5 half-lives, whichever is longer
- Photodynamic therapy for skin cancer or actinic keratoses ≥ 12 weeks
- Any toxicity attributable to prior anti-cancer therapy must be resolved to the patient's baseline level or ≤ Grade 1 (except alopecia).
Adequate bone marrow and organ function, defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
- Platelet count ≥ 100,000 cells/mm3
- Hemoglobin (Hgb) ≥ 8 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN (unless Gilbert's syndrome, then patients may be eligible if total serum bilirubin is ≤ 3.0 x ULN or direct bilirubin is ≤ 1.5 x ULN)
- Creatinine clearance (CrCL) as estimated by Cockcroft-Gault equation of ≥ 50 mL/min
- Adequate coagulation function defined as PT (prothrombin time)/PTT (partial thromboplastin time) within normal institutional values
Males or non-pregnant, non-lactating females who are postmenopausal, surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective contraceptive methods as defined by the protocol during the study and for 30 days after the last investigational treatment, see Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) concentration ≥ 40 IU/L, or at least 6 weeks following surgical menopause (bilateral oophorectomy).
a. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Part C, Surgical group only: Tumor resection surgery is clinically indicated and planned for the patient, regardless of study participation
Key Exclusion Criteria:
- Primary infratentorial or brainstem tumors
- Primary spinal cord tumors
- Bihemispheric disease (enhancing or non-enhancing) or tumors that involve the bilateral corpus callosum
- Women who are pregnant or breastfeeding
- Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
- Hypersensitivity to 5-ALA or porphyrins
Average skull thickness at the treatment field > 10 mm as assessed by Alpheus Medical.
The treatment field is defined as the various locations on the head where the transducer will be coupled to the patient. The average skull thickness at each treatment field will be determined by Alpheus Medical through post-processing the thin cut head computed tomography (CT) (without contrast). The patient's CT scan must be provided to Alpheus Medical for evaluation as part of the Screening and Enrollment process.
- Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma surgery. History of prior intratumoral bleeding is not an exclusion criterion; however, patients with a history of prior intratumoral or intracranial bleeding will undergo a non-contrast head CT to exclude acute bleeding.
- Patients who have clinically significant edema requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids).
- Patients with progressive and rapid clinical deterioration that, in the opinion of the investigator, is likely to worsen during the first cycle of treatment or in the peri-operative interval (in the surgical cohort)
- Cumulative prior RT dose > 64 Gy
- Acute or chronic types of porphyria
- Gastrointestinal disorder that negatively affects absorption
- Known active hepatitis B or C (Note: testing is not required)
- Known human immunodeficiency virus (HIV) infection (Note: testing is not required)
- Unable to avoid phototoxic drugs (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines) for 24 hours prior to and following 5-ALA administration
- Any other concurrent severe or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, cardiac disease, clinically significant psychiatric or neurological disorder, active or uncontrolled infection)
- Patient has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 5-ALA with CV01
5-aminolevulinic acid [5-ALA] with CV01-delivered ultrasound
|
5-aminolevulinic acid [5-ALA] administered orally 20 mg/kg every 4 weeks
Other Names:
CV01-delivered ultrasound every 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (Safety and Tolerability)
Time Frame: 12 Months
|
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)
|
12 Months
|
To determine the Maximum Tolerable Duration (MTDu)
Time Frame: 12 Months
|
The MTDu is defined as the highest duration at which fewer than 1/3 of patients experience a Duration limited toxicity
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Overall response rate (ORR)
Time Frame: 12 Months
|
ORR assessed by RANO criteria
|
12 Months
|
Assessment of Duration of Response (DoR)
Time Frame: 12 Months
|
12 Months
|
|
Assessment of Overall survival (OS)
Time Frame: 12 Months
|
12 Months
|
|
Assessment of Progression free survival (PFS)
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV01-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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