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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Max tolerated dose (MTD) of ALA and radiation

Secondary outcome measures

Evaluation of adverse events and laboratory abnormalities

Response rate

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.

0 / 13Eligibility criteria met

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: ALA / Fractions of Radiotherapy

Frequently Asked Questions

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

What is the projected size of this experiment's cohort?

"Affirmative. As per the information on clinicaltrials.gov, this medical experiment is currently acquiring participants after being initially advertised on July 30th 2020 and last updated February 18th 2022. The investigators are looking to include 130 patients from 1 site within their study population."

Answered by AI

Are there any openings left to participate in this research endeavor?

"Affirmative. Information available on clinicaltrials.gov verifies that this trial is actively recruiting upon its initial posting in July 30th 2020, and the most recent update made was February 18 2021; 130 participants are needed from one site to complete the study."

Answered by AI

Have the FDA granted approval to Low dose radiation and ALA?

"Due to the limited amount of data regarding safety and efficacy, Low dose radiation and ALA have been assessed as having a 1 rating on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

5-aminolevulinic Acid In Advanced Malignancies

2020. "5-aminolevulinic Acid In Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04443686.