Your session is about to expire
← Back to Search
Photodynamic Therapy for Brain Cancer
Phase 1
Recruiting
Led By William R Potter, MA
Research Sponsored by Photolitec LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a Karnofsky performance status ≥ 70
Subject has recurrent or progressive tumor following standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up t o18 months
Awards & highlights
Study Summary
This trial 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.
Who is the study for?
This trial is for adults over 18 with recurrent brain tumors (glioblastoma or gliosarcoma) that can be surgically removed. They must have completed standard therapy, have good organ function and blood counts, not be on anticoagulants, agree to use contraception if of child-bearing potential, and understand the study's investigational nature.Check my eligibility
What is being tested?
The trial tests Photodynamic Therapy (PDT) using Photobac® as an add-on to surgery in treating brain tumors. PDT involves a special drug activated by light aimed at improving safety and effectiveness compared to current treatments.See study design
What are the potential side effects?
Potential side effects include temporary skin photosensitivity due to the photosensitizer used in PDT. Other risks may relate to typical surgical procedures such as bleeding or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out normal activities.
Select...
My cancer has returned or worsened after standard treatment.
Select...
I have been diagnosed with glioblastoma or gliosarcoma.
Select...
I am 18 years old or older.
Select...
I haven't taken any blood thinners like warfarin or aspirin for 5 days before my surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure Photobac® concentration in tumor tissue removed during resection and in the bed of the tumor both before and after ligh treatment.
Measure the Photobac concentration in blood.
Overall survival from time of diagnosis
+3 moreSecondary outcome measures
Assess patterns of treatment failure for any association with the drug dose
Duration and severity of skin photosensitivity t osimulated sunlight .
Measure Stat 3 Crosslinking as a quantitative marker of singlet oxygen tissue damage
Trial Design
1Treatment groups
Experimental Treatment
Group I: Photochemotherapy as an adjuvant to surgical resection of glioblastomaExperimental Treatment1 Intervention
3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester (Photobac®) is injected 24 hours prior to surgical resection of a recurrent Glioblastoma or gliosarcoma. Immediately following the resection the cavity is treated with 50 joules/ square cm of 787 nm light .The drug dose is escalated using three patient cohorts until a dose limiting toxicity is reached or the upper limit of the 8 step escalation is reached.
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteOTHER
402 Previous Clinical Trials
30,777 Total Patients Enrolled
5 Trials studying Glioblastoma
128 Patients Enrolled for Glioblastoma
Photolitec LLCLead Sponsor
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,143 Total Patients Enrolled
322 Trials studying Glioblastoma
23,085 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with gliomatosis cerebri.You have an allergy to latex.I finished my radiation and TMZ treatment for brain cancer over 30 days ago.I do not have a serious illness or infection that would make anesthesia risky for me.I still experience side effects from previous cancer treatments.You have a condition called porphyria, or you are sensitive to certain substances that cause skin sensitivity to light.You have taken a new, experimental drug within the last month before the planned treatment.I have HIV/AIDS or another serious illness.My cancer has spread to my brainstem, spinal cord, or cerebellum.My brain tumor cannot be surgically removed.I do not have any bleeding disorders or conditions that increase my risk of bleeding.I am mostly able to care for myself and carry out normal activities.I am willing and able to follow the study's requirements.I am unable to give consent for the study.I've had chemotherapy or experimental treatment along with radiation and temozolomide within the last 30 days.My cancer has returned or worsened after standard treatment.I have been diagnosed with glioblastoma or gliosarcoma.I am 18 years old or older.My heart's electrical cycle is longer than normal.I cannot have MRI scans or use gadolinium contrast due to health reasons.My brain tumor has come back and can be removed by surgery.I haven't taken any blood thinners like warfarin or aspirin for 5 days before my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Photochemotherapy as an adjuvant to surgical resection of glioblastoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this experiment still open?
"The clinical trial hosted on the website, initially posted November 15th 2022 and last updated September 26th, is not currently recruiting participants. However, 443 other studies are open to applicants presently."
Answered by AI
To what extent could the use of Photobac® be hazardous for patients?
"Photobac® photochemotherapy is assessed as a 1 on the scale of safety due to its Phase 1 status, indicating sparse evidence in support of both efficacy and security."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger