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Intracavitary Photodynamic Therapy with Photobac® for Glioblastoma or Gliosarcoma

This study is testing a new treatment called Intracavitary Photodynamic Therapy (PDT) using a drug called Photobac® for people with recurrent glioblastoma or gliosarcoma. PDT combines light and a special drug (photosensitizer) to kill cancer cells. You would receive an intravenous (IV) injection of Photobac® 24 hours before surgery to remove your tumor. After the surgeon removes as much of the tumor as possible, the area where the tumor was will be treated with a special light for about 50 minutes. This treatment aims to destroy any remaining cancer cells. This first study will look at the safety of Photobac® and the light treatment, how much Photobac® is in your blood, and the highest safe dose of the drug. The study plans to enroll 30 participants who are at least 18 years old and have a good performance status (Karnofsky score of 70 or higher). The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to evaluate the safety of Photobac® and determine the maximum tolerable drug dose, with a planned enrollment of 30 participants.
What's involved
You would receive an IV injection of Photobac® 24 hours before surgery. The light treatment during surgery would add a maximum of 50 minutes to the procedure. Your blood will be tested for Photobac® concentration for up to 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Toxicity will be measured for up to 24 hours, and Photobac® concentration in blood will be measured for up to 12 weeks.

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NCT05363826

Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®

UNKNOWN
PHASE1Ages 18+InterventionalTreatment
Photolitec LLC
~30 participants
Updated 2023-04-13 on ClinicalTrials.gov
What's tested:photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events
Measured over .up to 24 hours
+5 more outcomes measured

Conditions

Glioblastoma Multiforme of Brain
Glioma, Sarcomatous

Explore related trials

GlioblastomaGliosarcoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • William R Potter, MA · PRINCIPAL_INVESTIGATOR · Photolitec LLC
  • Robert Fenstermaker, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Dept of Neurosurgery

Who to contact

Ravindra Pandey, PhD
[email protected]
800-767-9355 · ext. 3203
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Eligibility criteria

Inclusion

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.

What this trial measures

  • Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events.up to 24 hours

    •A dose limiting toxicity (DLT)will stop the escalation. A DLT includes all greater than or equal to grade 3 non-hematological toxicities and all greater than or equal to grade 4 hematological toxicities per CTCAE v 5.0

  • The Maximum Tolerable drug Dose (MTD) will be determined by evaluating the safety of a fixed light dose and escalating drug doseup to one week

    The MTD will be determined by first discovering the dose limiting toxicity ( DLT). As defined above and following the procedure for determining the MTD from the DLT found in the protocol. It is expected that the DLT may be acute neurotoxicity caused by brain swelling.

  • Measure the Photobac concentration in blood.up to12 weeks

    Photobac® concentration in blood will be measured by drawing blood at various time points. The blood will be spun down and the concentration in the serum measured spectroscopically. Non-linear regression will be used to determine the clearance rate constants from these data.

  • Measure Photobac® concentration in tumor tissue removed during resection and in the bed of the tumor both before and after ligh treatment.1 hour

    The tissue samples will be subject to chemical extraction of the Photobac®. Photobac® concentration in the extract will be measured spectroscopically.

  • Time of Progression Free Survivalup t o18 months

    The duration of progression free survival will be assessed by a Roswell neuroradiologist using RANO criteria.

  • Overall survival from time of diagnosisup to 18 months

    Patients will be followed for the duration of the study and if possible until death.