5-ALA for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fox Chase Cancer Center, Philadelphia, PASolid Tumors5-ALA - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 45 Days

45 Days
Maximum Tolerated Dose

Trial Safety

Safety Progress

1 of 3

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Side Effects for

5-ALA and Gliadel Wafers
14%seizure
8%muscle weakness
7%neutrophil count decreased
7%platelet count decreased
7%nausea
7%thrombolytic event
5%white blood cell decreased
5%vomiting
5%wound infection
5%thromboembolic event
5%lethargy
3%cerebral spinal fluid leak
3%infections other (not specified)
3%sepsis
2%hematoma
2%pulmonary edema
2%retinal detachment
2%fever
2%intra-abdomial hemorrhage
2%infection - cerebral abscess
2%muscle weakness left sided
2%stroke
2%Wound dehiscence
2%headache
2%vasovagal reaction
2%psychiatric disorders - other (steroid induced aggression)
2%urinary tract infection
2%other - bowel perforation
2%colonic perforation
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT01310868) in the 5-ALA and Gliadel Wafers ARM group. Side effects include: seizure with 14%, muscle weakness with 8%, neutrophil count decreased with 7%, platelet count decreased with 7%, nausea with 7%.

Trial Design

1 Treatment Group

5-ALA
1 of 1

Experimental Treatment

130 Total Participants · 1 Treatment Group

Primary Treatment: 5-ALA · No Placebo Group · Phase 1

5-ALA
Drug
Experimental Group · 1 Intervention: 5-ALA · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aminolevulinic acid
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 45 days

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
216 Previous Clinical Trials
34,417 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 20 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be willing to have an MRI scan.
You are able and willing to undergo PET/MRI imaging.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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