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
Photolitec LLC
Summary
This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective. Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success. For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that: 1. has no significant systemic toxicity apart from some temporary skin photosensitivity, 2. crosses the blood brain barrier, 3. accumulates to a high level in glioblastoma and minimally in the brain, 4. is activated by the wavelength of light that penetrates most deeply into the brain, 5. minimizes any temporary skin photosensitivity. Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.
Description
Twenty four hours before surgery the patient will receive an intravenous injection of Photobac®. This will make the brain tumor sensitive to light. Lighting up the brain using a low power near infrared laser will kill cells that contain Photobac®. Photobac® crosses the blood brain barrier. Compared to the brain at 24 hours after injection, the tumor holds significantly more Photobac®. This Selective retention by tumors is the reason PDT has proved a valuable weapon against other types of tumors. Once the surgeon has removed the tumor as completely as possible, the brain that bordered the tum…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 neutroph…
Interventions
- Combination Productphotochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)
Intravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF. Immediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery
Location
- Roswell Park CancerBuffalo, New York