Using light therapy to enhance surgery for brain tumors

Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator

This study is testing if using light therapy along with surgery can help people with brain tumors have better outcomes and lower chances of the tumor coming back.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Photolitec LLC (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT05363826 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of combining Photobac® Photodynamic Therapy with surgical resection of glioblastoma or gliosarcoma. Patients will receive an intravenous injection of Photobac® 24 hours prior to surgery, making the tumor sensitive to light. During surgery, a low power near-infrared laser will be used to illuminate the tumor site, targeting residual cancer cells that may lead to recurrence. The goal is to improve surgical outcomes and reduce the likelihood of tumor regrowth.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of recurrent or progressive glioblastoma or gliosarcoma that is surgically resectable.

Not a fit: Patients with non-resectable tumors or those who have not had prior standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with glioblastoma or gliosarcoma.

How similar studies have performed: While photodynamic therapy has shown promise in treating various cancers, this specific approach for glioblastoma and gliosarcoma is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18years.
2. Subject has a Karnofsky performance status ≥ 70 (i.e. the subject must be able to care for himself/herself with occasional help from others; refer to Appendix G).
3. Subject has pathologically confirmed diagnosis of glioblastoma or gliosarcoma.
4. Subject has recurrent or progressive tumor following standard therapy.
5. Subject has recurrent cerebral tumor that in the opinion of the treating neurosurgeon is surgically resectable.
6. Subject has the following clinical laboratory values obtained within 14 days prior to registration:

   Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
   * Platelets ≥ 100 x 109/L Hemoglobin (Hgb) \> 9.0 g/dL Plasma total bilirubin: ≤ 1.5 x ULN ALT and AST ≤ 2.0 x ULN Creatinine clearance \>60 WBC ≥ 4000 INR ≤ 1.1 x ULN
7. Subject will have been off all anticoagulant therapy (e.g., warfarin, heparin, enoxaparin, rivaroxaban, apixaban, aspirin) for at least 5 days before surgery and Photobac® infusion.
8. No active bleeding or pathological condition that in the judgement of the principal investigator carries a high risk of bleeding
9. Subject of child-bearing potential "agrees to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and have a negative pregnancy test prior to starting study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
10. Subject has completed radiation therapy (RT) and temozolomide (TMZ) for the treatment of their glioblastoma or gliosarcoma at least 30 days prior to entry
11. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

1. Subject has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the subject to receive the treatment outlined in this protocol with reasonable safety.
2. Subject is pregnant or breast-feeding.
3. Subject has latex allergy.
4. Subject has received another chemotherapeutic or investigational agent in addition to radiation therapy and concomitant temozolomide treatment within 30 days of planned PDT.
5. Subject has persistent toxicity of prior therapy.
6. Subject has gliomatosis cerebri.
7. Subject has cerebral tumor that in the opinion of the treating neurosurgeon is unresectable.
8. Subject has brainstem, spinal cord or cerebellar involvement by tumor.
9. Subject has known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness.
10. Subject has contraindication to MRI scans or gadolinium contrast agent.
11. Subject has history of porphyria, hypersensitivity to porphyrin or porphyrin-like compounds or any other abnormal skin photosensitivity.
12. Subject is unwilling or unable to follow protocol requirements.
13. Subject has any condition which in the Investigator's opinion makes the subject unsuitable to receive the study drug. Must be reported.
14. Subject has any condition which in the treating neurosurgeon's opinion makes the subject unsuitable to undergo craniotomy for tumor resection.
15. Subject has received an investigational agent within 30 days prior to planned PDT.
16. Subject has midline shift \> 1 cm.
17. Subject is unable to give consent to participate in the study.
18. Subject has a QTC interval \> 470 milliseconds (CTCAE grade 1) using Frederica's QT correction formula.
19. Subject has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the subject to tolerate the added hour o anesthesia outlined in this protocol with reasonable safety.

Where this trial is running

Buffalo, New York

• Roswell Park Cancer — Buffalo, New York, United States (Recruiting)

Study contacts

• Principal investigator: William R Potter, MA — Photolitec LLC
• Study coordinator: Ravindra Pandey, PhD

Conditions Glioblastoma Multiforme of Brain; Glioma, Sarcomatous; Photochemo Therapy; Photo Dynamic Therapy; PDT