What is the mechanism of action of this treatment?

Glioblastoma treatments often include surgical resection, radiation therapy, and chemotherapy. Surgical resection aims to remove as much of the tumor as possible. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, inhibiting their ability to reproduce. Chemotherapy involves drugs that target rapidly dividing cells, including cancer cells. Photodynamic Therapy (PDT), like the Photobac® trial, uses a photosensitizer that accumulates in cancer cells and is activated by specific wavelengths of light, producing reactive oxygen species that kill the cancer cells. This targeted approach minimizes damage to surrounding healthy tissue, which is crucial for preserving brain function and improving the quality of life for Glioblastoma patients.

What side effects are associated with this type of intervention?

Photodynamic Therapy (PDT) for glioblastoma, such as the Photobac® trial, typically involves side effects like temporary skin photosensitivity, localized pain, and swelling at the treatment site. Other common treatments for glioblastoma include surgery, which can lead to infection, bleeding, and neurological deficits; radiation therapy, which may cause fatigue, hair loss, and cognitive changes; and chemotherapy, which often results in nausea, vomiting, and increased susceptibility to infections. Each treatment modality has its own risk profile, and side effects can vary based on individual patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral chemotherapy drug, and bevacizumab, an anti-angiogenic therapy. While traditional treatments like surgery, radiation, and chemotherapy are common, photodynamic therapy (PDT) is an emerging area of interest. PDT involves the use of a photosensitizer that, when activated by a specific wavelength of light, produces reactive oxygen species that kill cancer cells. Although specific FDA approvals for PDT in Glioblastoma are limited, ongoing research, such as the trial involving Photobac® Photodynamic Therapy, aims to establish its efficacy and safety in treating this aggressive brain cancer.

What other types of research exist?

Promising novel alternatives to Photobac® Photodynamic Therapy for Glioblastoma patients include: 1) Tumor Treating Fields (TTF) - a non-invasive treatment that uses electric fields to disrupt cancer cell division. 2) CAR-T cell therapy - a type of immunotherapy where a patient's T cells are modified to target glioblastoma cells. 3) Oncolytic virus therapy - using genetically modified viruses to selectively infect and kill cancer cells. 4) Advanced targeted therapies such as Bevacizumab (Avastin) - an anti-angiogenic drug that inhibits the growth of blood vessels that supply the tumor. 5) Proton beam therapy - a type of radiation therapy that uses protons rather than X-rays to treat cancer, offering more precise targeting of tumor cells.

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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

Subject has a Karnofsky performance status ≥ 70

Subject has recurrent or progressive tumor following standard therapy

Must not have

Subject has gliomatosis cerebri

Subject has persistent toxicity of prior therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up t o18 months

Awards & highlights

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 am mostly able to care for myself and carry out normal activities.

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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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I haven't taken any blood thinners like warfarin or aspirin for 5 days before my surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with gliomatosis cerebri.

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I still experience side effects from previous cancer treatments.

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I have HIV/AIDS or another serious illness.

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My cancer has spread to my brainstem, spinal cord, or cerebellum.

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I am willing and able to follow the study's requirements.

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I am unable to give consent for the study.

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My heart's electrical cycle is longer than normal.

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I cannot have MRI scans or use gadolinium contrast due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments often include surgical resection, radiation therapy, and chemotherapy. Surgical resection aims to remove as much of the tumor as possible. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, inhibiting their ability to reproduce. Chemotherapy involves drugs that target rapidly dividing cells, including cancer cells. Photodynamic Therapy (PDT), like the Photobac® trial, uses a photosensitizer that accumulates in cancer cells and is activated by specific wavelengths of light, producing reactive oxygen species that kill the cancer cells. This targeted approach minimizes damage to surrounding healthy tissue, which is crucial for preserving brain function and improving the quality of life for Glioblastoma patients.