5-ALA Photodynamic Therapy for Cancer
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 Based on thus-far unpublished data, this treatment appears to be both safe and well-tolerated.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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orally-administered 5-aminolevulinic acid (ALA) as a radiosensitizer prior to low-dose radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5-ALA
5-ALA is already approved in United States, European Union for the following indications:
- Actinic keratosis
- Visualization of malignant tissue during glioma surgery
- Visualization of malignant tissue during glioma surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor