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

Inclusion Criteria:

1. Age ≥ 18years.
2. Subject has a Karnofsky performance status ≥ 70 (i.e. the subject must be able to carefor 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 neurosurgeonis surgically resectable.
6. Subject has the following clinical laboratory values obtained within 14 days prior toregistration: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelets ≥ 100 x 109/L Hemoglobin (Hgb) > 9.0 g/dL Plasma total bilirubin: ≤ 1.5x 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 andPhotobac® infusion.
8. No active bleeding or pathological condition that in the judgement of the principalinvestigator 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 entryand have a negative pregnancy test prior to starting study treatment. Should a womanbecome pregnant or suspect she is pregnant while she or her partner is participatingin this study, she should inform her treating physician immediately.
10. Subject has completed radiation therapy (RT) and temozolomide (TMZ) for the treatmentof their glioblastoma or gliosarcoma at least 30 days prior to entry
11. Participant must understand the investigational nature of this study and sign anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure.

Exclusion Criteria:

1. Subject has serious concurrent infection or medical illness, which in the treatingphysician's opinion would jeopardize the ability of the subject to receive thetreatment 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 toradiation therapy and concomitant temozolomide treatment within 30 days of plannedPDT.
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 isunresectable.
8. Subject has brainstem, spinal cord or cerebellar involvement by tumor.
9. Subject has known human immunodeficiency virus (HIV) positivity or acquiredimmunodeficiency 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-likecompounds 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 subjectunsuitable to receive the study drug. Must be reported.
14. Subject has any condition which in the treating neurosurgeon's opinion makes thesubject 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 QTcorrection formula.
19. Subject has serious concurrent infection or medical illness, which in the treatingphysician's opinion would jeopardize the ability of the subject to tolerate the addedhour o anesthesia outlined in this protocol with reasonable safety.