130 Participants Needed

5-ALA Photodynamic Therapy for Cancer

AO
AM
Overseen ByAlex Martinez
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

RDT aims to take advantage of the relatively safer toxicity profiles of both lower dose radiation therapy and systemic ALA to treat non-superficial lesions in a manner similar to photodynamic therapy. The doses of radiation administered in this study will be lower than those typically used to treat cancer. However, with administration of ALA, which has been shown to be selectively concentrated in neoplastic cells, it is reasonable to expect responses in the target lesion(s) with relative sparing of nearby normal structures. A similar therapy is currently being used in a single institution in China. Members of the Fox Chase Cancer Center have visited the Chinese medical site multiple times and have gained first-hand experience with this therapy. Based on thus-far unpublished data, this treatment appears to be both safe and well-tolerated. There have been marked responses seen in some of these patients, but this therapy has not yet been investigated in a more formalized clinical trial setting, nor has it been used on Western patients. Thus, while these findings are encouraging, much work is necessary to determine the efficacy and role of this intervention.

Do I need to stop my current medications to join the trial?

The trial requires that all previous cancer therapies, including radiotherapy, major surgery, and investigational therapies, be stopped for at least 14 days before starting the trial treatment. However, the protocol does not specify if you need to stop other non-cancer medications.

What data supports the effectiveness of the treatment 5-ALA Photodynamic Therapy for Cancer?

Research shows that 5-ALA, when used in photodynamic therapy, can effectively target and kill cancer cells by accumulating a light-sensitive substance in tumors, which is then activated by light to destroy the cells. Studies have demonstrated its effectiveness in various cancer types, including stomach and bladder cancer, by significantly slowing tumor growth and improving treatment outcomes.12345

Is 5-ALA photodynamic therapy generally safe for humans?

5-ALA photodynamic therapy is generally considered safe, but it can cause some side effects like nausea, vomiting, and temporary liver function changes. Some patients may experience low blood pressure during treatment, and there is a risk of skin sensitivity to light for a short period.678910

What makes 5-ALA photodynamic therapy unique for cancer treatment?

5-ALA photodynamic therapy is unique because it uses a naturally occurring compound that is converted into a photosensitive product in cancer cells, allowing targeted treatment with light exposure. Unlike synthetic photosensitizers, 5-ALA is rapidly metabolized, reducing the risk of prolonged skin sensitivity to light.27111213

Eligibility Criteria

Adults with advanced solid tumors resistant to standard therapy or without available standard options can join. They must have finished previous cancer treatments at least 14 days prior and be in stable condition, with good organ function and blood pressure. Participants need the ability to undergo PET/MRI imaging, not have active infections requiring IV treatment, no HIV/AIDS-related illness, not be pregnant or breastfeeding, and agree to use effective contraception.

Inclusion Criteria

My kidney function tests are within the required range.
I must be able to undergo PET/MRI imaging to participate.
I can take care of myself but might not be able to do heavy physical work.
See 19 more

Exclusion Criteria

You have a known history of porphyria, a medical condition that affects how your body produces certain substances.
You have a serious medical or mental health condition, or abnormal lab results, that could make it risky for you to participate in the study or affect the study results.
I am currently being treated for a minor infection with pills.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orally-administered 5-aminolevulinic acid (ALA) as a radiosensitizer prior to low-dose radiation therapy

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • 5-ALA
Trial OverviewThe trial is testing a combination of low-dose radiation therapy and systemic ALA (5-aminolevulinic acid) on non-superficial lesions. This approach aims for targeted responses while sparing healthy tissue. It's based on promising but unpublished Chinese data showing safety and marked responses in some patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 5-ALAExperimental Treatment1 Intervention
orally-administered 5-aminolevulinic acid (ALA) given as a radiosensitizer prior to low-dose radiation therapy (RT)

5-ALA is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as 5-aminolevulinic acid for:
  • Actinic keratosis
  • Visualization of malignant tissue during glioma surgery
🇪🇺
Approved in European Union as 5-aminolevulinic acid for:
  • Visualization of malignant tissue during glioma surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Findings from Research

5-Aminolevulinic acid is a highly specific photosensitizer that has been effectively used in diagnosing and treating urological cancers, particularly bladder cancer, through techniques like photodynamic diagnosis and therapy.
This compound works by exploiting the Warburg effect, a common characteristic of cancer cells, suggesting its potential application in treating a wide range of cancer types beyond urological cancers.
Current status of photodynamic technology for urothelial cancer.Inoue, K., Fukuhara, H., Yamamoto, S., et al.[2022]
5-Aminolevulinic acid (5-ALA) combined with photodynamic therapy (ALA-PDT) using violet and green LEDs was effective in treating peritoneally disseminated gastric cancer in a mouse model, showing significant necrotic areas in cancer nodules compared to controls.
The study found that violet and green LEDs generated more reactive oxygen species and had stronger anticancer effects than red LEDs, highlighting the importance of selecting the optimal light wavelength for effective treatment.
5-Aminolevulinic acid-mediated photodynamic therapy using light-emitting diodes of different wavelengths in a mouse model of peritoneally disseminated gastric cancer.Hino, H., Murayama, Y., Nakanishi, M., et al.[2013]
A systematic review of 77 studies on 5-aminolevulinic acid (5-ALA) photodynamic therapy (PDT) showed that it is particularly effective against stomach cancer, indicating a cancer-type sensitivity to this treatment.
The review suggests the need for a standardized experimental protocol for 5-ALA PDT to improve consistency and reliability in future research and clinical applications.
Systematic Review and Meta-Analysis of In Vitro Anti-Human Cancer Experiments Investigating the Use of 5-Aminolevulinic Acid (5-ALA) for Photodynamic Therapy.Shinoda, Y., Kato, D., Ando, R., et al.[2021]

References

Current status of photodynamic technology for urothelial cancer. [2022]
5-Aminolevulinic acid-mediated photodynamic therapy using light-emitting diodes of different wavelengths in a mouse model of peritoneally disseminated gastric cancer. [2013]
Systematic Review and Meta-Analysis of In Vitro Anti-Human Cancer Experiments Investigating the Use of 5-Aminolevulinic Acid (5-ALA) for Photodynamic Therapy. [2021]
Improvement of systemic 5-aminolevulinic acid-based photodynamic therapy in vivo using light fractionation with a 75-minute interval. [2013]
Antitumor effect of combination of hyperthermotherapy and 5-aminolevulinic acid (ALA). [2016]
5-Aminolevulinic acid-induced severe hypotension during transurethral resection of a bladder tumor: a case report. [2020]
Subcellular phototoxicity of 5-aminolaevulinic acid (ALA). [2019]
Side effects and photosensitization of human tissues after aminolevulinic acid. [2016]
Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light. [2013]
Sensitization and photodynamic therapy (PDT) of gastrointestinal tumors with 5-aminolaevulinic acid (ALA) induced protoporphyrin IX (PPIX). A pilot study. [2016]
α-Bisabolol improves 5-aminolevulinic acid retention in buccal tissues: Potential application in the photodynamic therapy of oral cancer. [2019]
The use of 5-aminolaevulinic acid as a photosensitiser in photodynamic therapy and photodiagnosis. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Topical versus Systemic 5-Aminolevulinic Acid Administration for Photodynamic Therapy of the Colon in B10.RBP Mice. [2019]