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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
Must not have
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (testing is not required for eligibility)
Active bacterial, fungal or viral infection, including hepatitis B (HBV) or hepatitis C (HCV), requiring treatment with intravenous antibiotic, anti-fungal, or anti-viral medications (testing is not required for eligibility).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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 It's based on promising but unpublished Chinese data showing safety and marked responses in some patients.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV/AIDS.
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I do not have an active infection needing IV treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose

Side effects data

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
234 Previous Clinical Trials
39,243 Total Patients Enrolled

Media Library

Solid Tumors Research Study Groups: 5-ALA
~26 spots leftby Feb 2026
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