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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
No active bleeding or pathological condition that in the judgement of the principal investigator carries a high risk of bleeding
Subject has a Karnofsky performance status ≥ 70
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 below
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I do not have any bleeding disorders or conditions that increase my risk of bleeding.
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I am mostly able to care for myself and carry out normal activities.
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I finished my radiation and TMZ treatment for brain cancer over 30 days ago.
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My cancer has returned or worsened after standard treatment.
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I have been diagnosed with glioblastoma or gliosarcoma.
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I am 18 years old or older.
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My brain tumor has come back and can be removed by surgery.
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I haven't taken any blood thinners like warfarin or aspirin for 5 days before my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

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 more
Secondary 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
30,828 Total Patients Enrolled
5 Trials studying Glioblastoma
128 Patients Enrolled for Glioblastoma
Photolitec LLCLead Sponsor
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,123 Total Patients Enrolled
322 Trials studying Glioblastoma
23,085 Patients Enrolled for Glioblastoma

Media Library

photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) Clinical Trial Eligibility Overview. Trial Name: NCT05363826 — Phase 1
Glioblastoma Research Study Groups: Photochemotherapy as an adjuvant to surgical resection of glioblastoma
Glioblastoma Clinical Trial 2023: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) Highlights & Side Effects. Trial Name: NCT05363826 — Phase 1
photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363826 — Phase 1

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
~15 spots leftby May 2025