Actively Recruiting
Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®
Led by Photolitec LLC · Updated on 2023-04-13
30
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
P
Photolitec LLC
Lead Sponsor
R
Roswell Park Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status 70 or higher (able to care for self with some help)
- Pathologically confirmed glioblastoma or gliosarcoma diagnosis
- Recurrent or progressive brain tumor after standard therapy
- Tumor considered surgically removable by treating neurosurgeon
- Adequate blood counts and liver/kidney function within 14 days before registration
- Off all anticoagulant medications for at least 5 days before surgery
- No active bleeding or conditions with high bleeding risk
- For women of child-bearing potential: use effective contraception and negative pregnancy test before treatment
- Completed radiation therapy and temozolomide at least 30 days prior to study entry
- Able to understand the trial and provide informed consent
You will not qualify if you...
- Serious infection or medical illness that would make treatment unsafe
- Pregnant or breastfeeding
- Allergy to latex
- Received other chemotherapy or investigational drugs within 30 days before PDT
- Persistent side effects from prior therapies
- Diagnosis of gliomatosis cerebri
- Tumor deemed not removable by surgery
- Tumor involvement of brainstem, spinal cord, or cerebellum
- Known HIV infection or AIDS or other serious illnesses
- Cannot have MRI or gadolinium contrast
- History of porphyria or abnormal skin sensitivity to light
- Unable or unwilling to follow study procedures
- Any condition making participant unsuitable for study drug or surgery
- Midline brain shift greater than 1 cm
- Unable to provide informed consent
- Prolonged QT interval on heart monitoring
- Serious infection or illness that would prevent tolerating extended anesthesia time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
R
Ravindra Pandey, PhD
CONTACT
W
William R Potter, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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