photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) for Glioma, Sarcomatous

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Roswell Park Cancer, Buffalo, NY
Glioma, Sarcomatous+3 More
photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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: has no significant systemic toxicity apart from some temporary skin photosensitivity, crosses the blood brain barrier, accumulates to a high level in glioblastoma and minimally in the brain, is activated by the wavelength of light that penetrates most deeply into the brain, 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.

Eligible Conditions

  • Glioma, Sarcomatous
  • Glioblastoma Multiforme of Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: up t o18 months

.up to 24 hours
Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events
1 hour
Measure Photobac® concentration in tumor tissue removed during resection and in the bed of the tumor both before and after ligh treatment.
Measure Stat 3 Crosslinking as a quantitative marker of singlet oxygen tissue damage
1 week
Duration and severity of skin photosensitivity t osimulated sunlight .
up t o18 months
Time of Progression Free Survival
up to 15 months.
Assess patterns of treatment failure for any association with the drug dose
up to 18 months
Overall survival from time of diagnosis
up to one week
The Maximum Tolerable drug Dose (MTD) will be determined by evaluating the safety of a fixed light dose and escalating drug dose
up to12 weeks
Measure the Photobac concentration in blood.

Trial Safety

Trial Design

1 Treatment Group

Photochemotherapy as an adjuvant to surgical resection of glioblastoma
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) · No Placebo Group · Phase 1

Photochemotherapy as an adjuvant to surgical resection of glioblastoma
CombinationProduct
Experimental Group · 1 Intervention: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up t o18 months
Closest Location: Roswell Park Cancer · Buffalo, NY
Photo of roswell park cancer institute  1Photo of roswell park cancer institute  2Photo of roswell park cancer institute  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Glioma, Sarcomatous
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are scheduled to undergo surgery and you have been off anticoagulant therapy for at least 5 days.
You have a pathologically confirmed diagnosis of glioblastoma or gliosarcoma.
You have a recurrent cerebral tumor that in the opinion of the treating neurosurgeon is surgically resectable.
You are of child-bearing potential and agree 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.