Photodynamic Therapy for Brain Cancer

Overseen by Robert Fenstermaker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Photolitec LLC

Must not be taking: Anticoagulants, Chemotherapy

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment combining a special drug and light therapy with surgery for brain cancer patients. The drug makes cancer cells sensitive to light, and during surgery, doctors use a special light to kill these cells. This approach aims to reduce the chances of the tumor coming back. This method has great potential in treating serious illnesses.

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 data supports the effectiveness of the treatment Photobac® for brain cancer?

Research shows that Photobac®, used in photodynamic therapy (PDT), has been effective in animal models for treating brain tumors, with promising results in extending survival times. Additionally, PDT has shown potential in increasing survival rates for patients with malignant brain tumors compared to standard treatments. ^{1 2 3 4 5}

Is Photodynamic Therapy (PDT) safe for treating brain cancer?

Photodynamic Therapy (PDT), including treatments like Photobac®, has shown limited toxicity in animal studies and was generally well tolerated in human trials, with mild side effects such as increased sensitivity to sunlight and occasionally increased pressure in the brain. ^{1 2 4 6 7}

How does photodynamic therapy differ from other treatments for brain cancer?

Photodynamic therapy (PDT) for brain cancer is unique because it uses a photosensitizing compound that accumulates in tumor cells and is activated by light to produce a toxic form of oxygen, selectively destroying cancer cells. This approach not only directly kills tumor cells but also stimulates an immune response, potentially enhancing its effectiveness compared to standard treatments. Additionally, PDT has shown promise in prolonging survival in patients with glioblastoma, a type of brain cancer with limited treatment options. ^{2 4 8 9 10}

Research Team

William R Potter, MA

Principal Investigator

Photolitec LLC

Robert Fenstermaker, MD

Principal Investigator

Roswell Park Dept of Neurosurgery

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Photobac® (Photosensitizer)

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.

Participant Groups

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+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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) 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) 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]

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) 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) 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) 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]

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]

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]

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]

References

1. Ukraine pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in the treatment of glioma. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Photodynamic diagnosis and therapy and the brain. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Cerebral edema following photodynamic therapy using endogenous and exogenous photosensitizers in normal brain. [2021]

4. France 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. [2023]

5. Singapore pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumours. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Role of photodynamic therapy using talaporfin sodium and a semiconductor laser in patients with newly diagnosed glioblastoma. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy for Malignant Brain Tumors. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of malignant glioma. A review of literature. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Photoradiation therapy of brain tumours. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy mediated immune therapy of brain tumors. [2020]