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Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma

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ClinicalTrials.gov Identifier: NCT05362409
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Alpheus Medical, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2022
First Posted Date  ICMJE May 5, 2022
Last Update Posted Date October 28, 2022
Actual Study Start Date  ICMJE June 29, 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2022)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2022)
  • Assessment of Overall response rate (ORR) [ Time Frame: 12 Months ]
    ORR assessed by RANO criteria
  • Assessment of Duration of Response (DoR) [ Time Frame: 12 Months ]
  • Assessment of Overall survival (OS) [ Time Frame: 12 Months ]
  • Assessment of Progression free survival (PFS) [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
Official Title  ICMJE 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)
Brief Summary 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)
Detailed Description High-grade gliomas are the most commonly occurring primary CNS tumors in adults. The investigational product in this clinical study is a drug-device combination product consisting of 5-ALA HCl oral solution and the CV01 ultrasound delivery device. 5-ALA will be administered as a sonosensitizer prior to CV01-delivered ultrasound and will be re-administered every 4 weeks prior to CV01 ultrasound delivery. The CV01 device will deliver non-ablative, low-intensity ultrasound to deep regions of the brain to induce apoptosis of cancer cells. This FIH study will evaluate escalating durations of ultrasound delivery with CV01 and will enroll up to 33 patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE High Grade Glioma
Intervention  ICMJE
  • Drug: 5 Aminolevulinic Acid
    5-aminolevulinic acid [5-ALA] administered orally 20 mg/kg every 4 weeks
    Other Names:
    • 5-ALA
    • Gleolan
  • Device: CV01-delivered ultrasound
    CV01-delivered ultrasound every 4 weeks
Study Arms  ICMJE Experimental: 5-ALA with CV01
5-aminolevulinic acid [5-ALA] with CV01-delivered ultrasound
Interventions:
  • Drug: 5 Aminolevulinic Acid
  • Device: CV01-delivered ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2022)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  1. Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
  2. ≥ 18 years of age
  3. WHO performance status of ≤ 2 at screening
  4. 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):

    1. Astrocytoma, WHO grade 3 and 4 (including subtypes)
    2. Oligodendroglioma WHO grade 3 (including subtypes)
  5. Unifocal or multifocal tumor confined to the supratentorial compartment
  6. Interval since last anti-cancer therapy relative to first 5-ALA treatment, as detailed below

    1. End of radiotherapy >12 weeks (including skin-directed radiation for skin cancer),
    2. Last cytotoxic chemotherapy (4 weeks, if prior nitrosureas 6 weeks).
    3. 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
    4. Any other investigational agent(s) ≥ 30 days or 5 half-lives, whichever is longer
    5. Photodynamic therapy for skin cancer or actinic keratoses ≥ 12 weeks
  7. Any toxicity attributable to prior anti-cancer therapy must be resolved to the patient's baseline level or ≤ Grade 1 (except alopecia).
  8. Adequate bone marrow and organ function, defined by the following laboratory values:

    1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
    2. Platelet count ≥ 100,000 cells/mm3
    3. Hemoglobin (Hgb) ≥ 8 g/dL
    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
    5. 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)
    6. Creatinine clearance (CrCL) as estimated by Cockcroft-Gault equation of ≥ 50 mL/min
  9. Adequate coagulation function defined as PT (prothrombin time)/PTT (partial thromboplastin time) within normal institutional values
  10. 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

  11. Agreement to adhere to Lifestyle Considerations throughout study duration

Key Exclusion Criteria:

  1. Primary infratentorial or brainstem tumors
  2. Primary spinal cord tumors
  3. Bihemispheric disease (enhancing or non-enhancing) or tumors that involve the bilateral corpus callosum
  4. Women who are pregnant or breastfeeding
  5. Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
  6. Hypersensitivity to 5-ALA or porphyrins
  7. 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.

  8. 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.
  9. Patients who have clinically significant edema requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids).
  10. 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 subgroup)
  11. Cumulative prior RT dose > 64 Gy
  12. Acute or chronic types of porphyria
  13. Gastrointestinal disorder that negatively affects absorption
  14. Known active hepatitis B or C (Note: testing is not required)
  15. Known human immunodeficiency virus (HIV) infection (Note: testing is not required)
  16. 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
  17. 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)
  18. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alpheus Medical (612) 234-4009 info@alpheusmedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05362409
Other Study ID Numbers  ICMJE CV01-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alpheus Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alpheus Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alpheus Medical, Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP