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5-ALA Photodynamic Therapy for Cancer

Phase 1
Recruiting
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Serum creatinine ≤ 1.5 X ULN AND Creatinine clearance (per eGFR) ≥ 40 mL/min/1.73 m2)
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights

Study Summary

This trial will use lower doses of radiation than usual to treat cancer, along with a drug called ALA that has been shown to be more effective in neoplastic cells. The goal is to create a treatment similar to photodynamic therapy that is safer for the patient.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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 It's based on promising but unpublished Chinese data showing safety and marked responses in some patients.See study design
What are the potential side effects?
While specific side effects are not listed here, the treatment is said to have a relatively safer toxicity profile compared to higher doses of radiation therapy. Potential risks may include those commonly associated with low-dose radiation and ALA administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function tests are within the required range.
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I can take care of myself but might not be able to do heavy physical work.
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I am willing to undergo MRI imaging.
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I have not been treated with bleomycin before radiation to my chest.
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I am 18 years old or older.
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I stopped all cancer treatments at least 14 days ago, and any side effects are mild or gone.
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My advanced cancer does not respond to standard treatments.
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My hemoglobin level is above 8.0 mg/dL without recent blood transfusions.
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My cancer diagnosis was confirmed through tissue or cell testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT01310868
14%
seizure
8%
muscle weakness
7%
nausea
7%
thrombolytic event
7%
neutrophil count decreased
7%
platelet count decreased
5%
wound infection
5%
white blood cell decreased
5%
lethargy
5%
vomiting
5%
thromboembolic event
3%
infections other (not specified)
3%
cerebral spinal fluid leak
3%
sepsis
2%
infection - cerebral abscess
2%
hematoma
2%
Wound dehiscence
2%
muscle weakness left sided
2%
pulmonary edema
2%
headache
2%
stroke
2%
vasovagal reaction
2%
retinal detachment
2%
fever
2%
intra-abdomial hemorrhage
2%
psychiatric disorders - other (steroid induced aggression)
2%
urinary tract infection
2%
other - bowel perforation
2%
colonic perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
5-ALA and Gliadel Wafers

Trial Design

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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aminolevulinic acid
FDA approved

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,379 Total Patients Enrolled

Media Library

Solid Tumors Research Study Groups: 5-ALA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have been conducted concerning 5-ALA?

"Currently, 18 studies investigating the effects of 5-ALA are underway with 2 reaching Phase 3. While these investigations have a major presence in Lebanon, New hampshire, there is also data collection taking place across 56 other medical centres."

Answered by AI

How many participants are being observed in this medical experiment?

"Affirmative. As documented on clinicaltrials.gov, this medical trial is actively recruiting individuals and had been first posted on July 30th 2020 with its most recent edit being August 10th 2022. Approximately 130 participants are needed from one site to complete the study's requirements."

Answered by AI

Has the Food and Drug Administration endorsed 5-ALA for therapeutic use?

"As this is a Phase 1 trial, there is restricted data available to attest to the safety of 5-ALA; thus, our team at Power assigned it a score of 1."

Answered by AI

How is 5-ALA regularly employed in medical treatment?

"5-ALA has been utilized to treat scalp structure, along with other ailments such as carcinoma, squamous cell carcinoma and facial conditions."

Answered by AI

Are there vacancies in this research initiative for participants?

"Yes, the latest information from clinicaltrials.gov discloses that this medical investigation is actively recruiting participants. First launched on July 30th 2020 and recently modified on August 10th 2022, it seeks to enrol 130 patients at 1 trial centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I Study in Advanced Malignancies With 5-ALA
2020. "Phase I Study in Advanced Malignancies With 5-ALA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04381806.
~41 spots leftby Feb 2026
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