Photodynamic Therapy for Brain Cancer

Overseen By William R Potter, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Photolitec LLC

Must not be taking: Anticoagulants, Chemotherapy

Disqualifiers: Pregnancy, HIV/AIDS, Unresectable tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for brain cancer, specifically glioblastoma or gliosarcoma. Researchers are examining whether adding Photobac® Photodynamic Therapy (PDT) to surgery is safe and effective. PDT uses special light and a drug called a photosensitizer to target cancer cells. Patients with a recurrent brain tumor after standard treatment, deemed surgically removable by their doctor, might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking all anticoagulant medications (like warfarin, heparin, and aspirin) at least 5 days before surgery and the Photobac® infusion. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What prior data suggests that Photodynamic Therapy is safe for treating brain cancer?

Research shows that Photodynamic Therapy (PDT) has treated various types of cancer with varying success. For Photobac®, the treatment under testing, early studies show promising results. Photobac® targets brain cancer cells while minimizing damage to healthy brain tissue.

The treatment aims to avoid major side effects, except for some temporary skin sensitivity to light. Patients might need to avoid strong sunlight for a short time after treatment. Research also highlights that Photobac® can cross the blood-brain barrier, which usually prevents harmful substances from reaching the brain. This feature is crucial for effectively treating brain tumors.

Currently, Photobac® is in the early stages of human testing, focusing mainly on safety. So far, results have been positive enough to advance into human trials. However, more data is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glioblastoma, which often involve surgery, radiation, and chemotherapy, Photobac® introduces a novel approach called photodynamic therapy. This treatment involves injecting a special compound, 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester, before surgery. After the tumor is surgically removed, the area is exposed to a specific wavelength of light, activating the compound to target any remaining cancer cells directly. Researchers are excited about Photobac® because it offers a targeted method to attack cancer cells while potentially sparing healthy brain tissue, which could lead to better outcomes and fewer side effects compared to traditional therapies.

What evidence suggests that Photodynamic Therapy might be an effective treatment for brain cancer?

Research shows that Photodynamic Therapy (PDT) has been studied for treating various cancers, including brain tumors like glioblastoma. In animal studies, a type of PDT called Photobac® showed promising results in shrinking brain tumors in mice and rats. Photobac® uses a special drug activated by light to target tumor cells while leaving most normal brain tissue unharmed. This drug can cross the blood-brain barrier, which is crucial for treating brain tumors. In this trial, Photobac® will serve as an adjuvant to surgical resection of glioblastoma, with the drug injected 24 hours before surgery and the cavity treated with light immediately after resection. Although these early results are encouraging, human trials are needed to confirm its effectiveness and safety. ^{1 2 3 4 5}

Who Is on the Research Team?

William R Potter, MA

Principal Investigator

Photolitec LLC

Robert Fenstermaker, MD

Principal Investigator

Roswell Park Dept of Neurosurgery

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my radiation and TMZ treatment for brain cancer over 30 days ago.

INR ≤ 1.1 x ULN

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

Exclusion Criteria

I have been diagnosed with gliomatosis cerebri.

You have an allergy to latex.

I do not have a serious illness or infection that would make anesthesia risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous injection of Photobac® 24 hours before surgery, followed by surgical resection and intracavitary photodynamic therapy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival

up to 18 months

Monitoring

Measure Photobac® concentration in blood and assess skin photosensitivity

up to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photobac®

Trial Overview 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.

How Is the Trial Designed?

Group I: Photochemotherapy as an adjuvant to surgical resection of glioblastoma Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Photolitec LLC

Lead Sponsor

Trials

1

Recruited

30+

Roswell Park Cancer Institute

Collaborator

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Photodynamic therapy (PDT) shows promise in extending median survival for patients with malignant brain tumors, with 22 months for primary glioblastoma multiforme compared to 15 months with standard treatment.

PDT is generally well tolerated, though some patients may experience increased intracranial pressure and prolonged skin sensitivity to sunlight, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic diagnosis and therapy and the brain. Kostron, H.[2015]

Photodynamic therapy (PDT) effectively destroys tumors by using a photosensitizing compound activated by light, which generates singlet oxygen that damages cancer cells and induces cell death through various mechanisms, including apoptosis and immunogenic cell death.

PDT not only directly kills tumor cells but also enhances the immune response against tumors, suggesting its potential role in developing specific anti-tumor immunity and vaccines, particularly for brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy mediated immune therapy of brain tumors. Hirschberg, H., Berg, K., Peng, Q.[2020]

Photodynamic therapy (PDT) shows promising results in treating malignant brain tumors, with improved one and two-year survival rates compared to standard treatments.

Patients receiving PDT experienced an increase in overall median survival, suggesting that this therapy could be a beneficial option in neurooncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in the treatment of glioma. Zavadskaya, ТS.[2016]

Photodynamic therapy (PDT) using talaporfin sodium has shown promising efficacy in treating newly diagnosed glioblastoma, with 100% one-year survival and a median overall survival of 24.8 months in a study of 22 patients.

The treatment was found to have mild adverse effects, leading to its approval for health insurance coverage in Japan as a new intraoperative therapy for malignant brain tumors, highlighting its potential as a less invasive option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy for Malignant Brain Tumors. Akimoto, J.[2022]

Photobac, a near-infrared photosensitizer derived from bacteriochlorophyll-a, has shown effective photodynamic therapy (PDT) results in animal models with U87 and C6 tumors, leading to its approval for Phase I human clinical trials for glioblastoma.

Safety studies indicate that Photobac does not exhibit phototoxicity or toxicity to the brain or retina, and it has received orphan drug status from the US FDA due to its potential to treat glioblastoma, a cancer with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobac derived from bacteriochlorophyll-a shows potential for treating brain tumor in animal models by photodynamic therapy with desired pharmacokinetics and limited toxicity in rats and dogs. Durrani, FA., Cacaccio, J., Turowski, SG., et al.[2023]

Photodynamic therapy (PDT) using talaporfin sodium significantly improved progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed glioblastoma, with median PFS times of 19.6 months for the PDT group compared to 9.0 months for the control group.

The PDT group also showed a lower tendency for local tumor recurrence (10 out of 30 patients) compared to the control group (101 out of 164 patients), indicating effective local control with minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of photodynamic therapy using talaporfin sodium and a semiconductor laser in patients with newly diagnosed glioblastoma. Nitta, M., Muragaki, Y., Maruyama, T., et al.[2019]

Photodynamic therapy (PDT) effectively targets tumors by using a photosensitizer, like haematoporphyrin derivative (HpD), which selectively accumulates in various grades of gliomas, with the highest uptake in glioblastoma multiforme.

Clinical trials indicate that PDT is primarily used as an adjuvant therapy after tumor resection, showing promise in enhancing treatment outcomes for cerebral tumors, particularly when combined with stereotactic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumours. Kaye, AH., Hill, JS.[2020]

Photodynamic therapy (PDT) shows promise as an adjuvant treatment for malignant glioma by using a photosensitive dye that selectively targets tumor tissue for destruction when exposed to specific light.

Current clinical trials have involved a limited number of patients and varied treatment protocols, making it difficult to determine the overall efficacy of PDT for gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of malignant glioma. A review of literature. Noske, DP., Wolbers, JG., Sterenborg, HJ.[2019]

Photodynamic therapy (PDT) using the photosensitizer 5-aminolevulinic acid (ALA) resulted in less cerebral edema and lower mortality compared to aluminum phthalocyanine disulfonate (AlPcS2a), indicating ALA may be a safer option for treating high-grade gliomas.

The study utilized T2-weighted MR imaging to effectively monitor brain edema and blood-brain barrier dysfunction, demonstrating that this imaging technique can reduce the number of animals needed for research while providing valuable insights into treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral edema following photodynamic therapy using endogenous and exogenous photosensitizers in normal brain. Mathews, MS., Chighvinadze, D., Gach, HM., et al.[2021]

Photoradiation therapy has shown promise in selectively destroying cerebral gliomas, effectively reaching depths of up to 1 cm in tumor tissue, indicating its potential for localized treatment.

Clinical studies using haematoporphyrin derivative and red laser light have demonstrated that this therapy is well tolerated by patients and may serve as a valuable adjuvant treatment for cerebral tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoradiation therapy of brain tumours. Kaye, AH.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05363826

NCT05363826 | Intracavitary Photodynamic Therapy as an ... This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964779/

State-of-the-art photodynamic therapy for malignant gliomas This review provides a comprehensive analysis of the preclinical and clinical applications of PDT in GBM, detailing its mechanisms of action, the evolution of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666469023000027

Photodynamic therapy for glioblastoma: A light at the end ... Photodynamic therapy is an alternative therapy to treat several diseases, including tumors such as glioblastoma.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842770/

Photobac derived from bacteriochlorophyll-a shows ... The photodynamic therapy (PDT) efficacy of Photobac was evaluated in mice subcutaneously implanted with U87 tumors, and in rats bearing C6 tumors implanted in ...

5. trials.braintumor.org trials.braintumor.org/trials/NCT05363826

Intracavitary Photodynamic Therapy as an Adjuvant to ... 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 ...