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

Launched by PHOTOLITEC LLC · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with glioblastoma or gliosarcoma, which are aggressive types of brain tumors. The researchers want to find out if combining a special light therapy called Photodynamic Therapy (PDT) with surgery to remove the tumor is safe and effective. PDT uses a light-sensitive drug that targets the tumor cells when exposed to a specific type of light. This trial represents the first step in exploring how well this combination works to improve outcomes for patients.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of glioblastoma or gliosarcoma that has returned or progressed after standard treatments. They should be able to care for themselves with some help and must meet certain health criteria, like having a good blood count. Participants will undergo surgery followed by the light therapy, and they will be closely monitored for any side effects. This trial is an important opportunity for patients looking for new treatment options for these challenging brain tumors.

Gender

ALL

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.