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Photosensitizer

ALA + Radiation for Solid Cancers

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
Patients who refuse MRI imaging are not eligible
Patients previously treated with a bleomycin regimen are not permitted to undergo radiation therapy to the thorax
Must not have
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (testing is not required for eligibility)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment consisting of two drugs, ALA and RT. The purpose of the trial is to find the maximum tolerated doses of the drugs and to assess the safety and preliminary efficacy of the treatment. The trial will enroll at least 20 patients across a variety of tumor types.

Who is the study for?
Adults with advanced solid tumors resistant to standard treatments or without available standard therapies can join this trial. They must be able to undergo PET/MRI imaging, have stable vital signs and organ function, and not have had recent cancer treatments. Women of childbearing potential and men must agree to use contraception.
What is being tested?
The study is testing the safety and effectiveness of combining low dose radiation (RT) with a drug called ALA in escalating doses. It aims to find the highest dose patients can tolerate without severe side effects, then expand the trial for further safety evaluation and preliminary efficacy results.
What are the potential side effects?
Potential side effects may include reactions related to gastrointestinal function due to ALA absorption issues, as well as general risks associated with radiation therapy such as fatigue, skin changes, or nausea. Specific side effect profiles will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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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My white blood cell count is healthy without recent medication help.
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I am willing and able to undergo PET/MRI scans.
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I stopped all cancer treatments at least 14 days ago and have no severe side effects.
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I am 18 years old or older.
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My platelet count is above 75,000 without recent transfusions.
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My kidney function tests are within the required range.
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My hemoglobin is above 8.0 mg/dL without recent blood transfusions.
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My advanced cancer does not respond to standard treatments.
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My cancer was confirmed through tissue or cell testing.
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My cancer can be seen on a PET scan or MRI.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV/AIDS but haven't been tested for this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Max tolerated dose (MTD) of ALA and radiation
Secondary study objectives
Evaluation of adverse events and laboratory abnormalities
Response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALA / Fractions of RadiotherapyExperimental Treatment1 Intervention
Subjects will receive 3 doses of ALA and fractions of radiation therapy during the course of one 21day cycle. Only one cycle per patient is allowed.

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: ALA / Fractions of Radiotherapy
~24 spots leftby Feb 2026
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