RECRUITING

Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).

Official Title

A Phase 0, First in Human, Open-label Study of Intravenous Aminolevulinic Acid HCl (ALA) and MR-Guided Focused Ultrasound Device (MRgFUS) in Participants With Recurrent High Grade Glioma (HGG)

Quick Facts

Study Start:2021-03-15

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04559685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Arms A-D: Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard therapy as determined by the investigator. Arm E: Participant at first recurrence with an unmethylated HGG, has completed standard therapy and is not currently scheduled for resection. 2. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion. 3. Arms A-D (only): Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and ≤ 20cm3 of targeted treatment area. 4. Age ≥18 at time of consent. 5. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982). 6. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility) * absolute neutrophil count ≥1,000/mcL * Platelets (at time of surgery) ≥100,000/mcL * hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. * total bilirubin ≤1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted. * AST(SGOT) ≤3 X institutional ULN * ALT(SGPT) ≤3 X institutional ULN * GGT ≤3 X institutional ULN * Serum creatinine ≤1.5 X institutional ULN 7. Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy. 8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration. 9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid. 10. Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 14 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy). 11. Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1. 12. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). 13. Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. 14. Willingness and ability to comply with scheduled visits, treatment plans, Lifestyle Considerations, laboratory tests and other procedures.	1. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment. 2. Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke. 3. Significant vascular disease (e.g. aortic aneurysm) 4. Evidence of bleeding diathesis or coagulopathy 5. Diagnosis of porphyria 6. Unstable angina and/or congestive heart failure within the last 6 months 7. Transmural myocardial infarction within the last 6 months 8. Serious and inadequately controlled cardiac arrhythmia 9. Acute exacerbation of chronic obstructive pulmonary disease 10. Inability to undergo MRI (e.g., presence of a pacemaker) 11. Pregnancy or breastfeeding 12. Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. 13. Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) 14. Hypersensitivity against porphyrins 15. Treatment with another investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. 16. Has an Overall Skull Density Ratio of 0.45 (±0.05) or less as calculated from the screening CT.

Inclusion Criteria

Exclusion Criteria

1. Arms A-D: Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard therapy as determined by the investigator. Arm E: Participant at first recurrence with an unmethylated HGG, has completed standard therapy and is not currently scheduled for resection.
2. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion.
3. Arms A-D (only): Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and ≤ 20cm3 of targeted treatment area.
4. Age ≥18 at time of consent.
5. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982).
6. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility)
* absolute neutrophil count ≥1,000/mcL
* Platelets (at time of surgery) ≥100,000/mcL
* hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
* total bilirubin ≤1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
* AST(SGOT) ≤3 X institutional ULN
* ALT(SGPT) ≤3 X institutional ULN
* GGT ≤3 X institutional ULN
* Serum creatinine ≤1.5 X institutional ULN
7. Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy.
8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration.
9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.
10. Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 14 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy).
11. Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1.
12. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
13. Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
14. Willingness and ability to comply with scheduled visits, treatment plans, Lifestyle Considerations, laboratory tests and other procedures.

1. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
2. Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke.
3. Significant vascular disease (e.g. aortic aneurysm)
4. Evidence of bleeding diathesis or coagulopathy
5. Diagnosis of porphyria
6. Unstable angina and/or congestive heart failure within the last 6 months
7. Transmural myocardial infarction within the last 6 months
8. Serious and inadequately controlled cardiac arrhythmia
9. Acute exacerbation of chronic obstructive pulmonary disease
10. Inability to undergo MRI (e.g., presence of a pacemaker)
11. Pregnancy or breastfeeding
12. Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
13. Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
14. Hypersensitivity against porphyrins
15. Treatment with another investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
16. Has an Overall Skull Density Ratio of 0.45 (±0.05) or less as calculated from the screening CT.

Contacts and Locations

Study Contact

Phase 0 Navigator

CONTACT

602-406-8605

research@ivybraintumorcenter.org

Principal Investigator

Nader Sanai, MD

PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital and Medical Center, Phoenix

Study Locations (Sites)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

United States

Collaborators and Investigators

Sponsor: Nader Sanai

Nader Sanai, MD, PRINCIPAL_INVESTIGATOR, St. Joseph's Hospital and Medical Center, Phoenix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2021-03-15

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

High Grade Glioma