5-AminoLevulinic Acid for Cancer

(5-ALARMS Trial)

Overseen By Gregory Ottenberg

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Phototoxic substances

Disqualifiers: Porphyria, Uncontrolled illness, Recent chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons better visualize soft-tissue sarcomas during surgery. The treatment involves a fluorescent agent called 5-Aminolevulinic acid (5-ALA), which causes the tumor to illuminate under a special light in the operating room. Participants will take 5-ALA a few hours before surgery to determine if it enhances the visibility of cancerous tissue for more precise removal. The trial seeks individuals diagnosed with Grade 2 or 3 soft-tissue sarcomas who are planning surgery to remove the tumor. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should avoid using certain substances that can make your skin sensitive to light, like St. John's wort or some antibiotics, for 24 hours around the time of surgery.

What prior data suggests that this technique is safe for use in surgery?

Research has shown that 5-Aminolevulinic Acid (5-ALA) is generally safe for people. This substance has been used in surgeries and treatments involving light-sensitive drugs. Studies have found it well-tolerated when used to help identify tumor edges during surgery.

One study highlighted that 5-ALA has been safely used for various tumor types without major side effects. Another review of both animal and human studies also supports the safety of using low doses of 5-ALA. Although the current study remains in the early stages, existing evidence suggests that 5-ALA is a safe option for prospective participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for soft tissue sarcomas, which often involve surgery, radiation, and chemotherapy, 5-Aminolevulinic Acid (5-ALA) offers a unique approach. Researchers are excited about 5-ALA because it is a prodrug that turns into a compound that makes cancer cells glow under special light. This helps surgeons to see and remove cancerous tissues more precisely during surgery. This innovative method potentially increases the accuracy of tumor removal and reduces the likelihood of cancer cells being left behind, which can improve patient outcomes.

What evidence suggests that 5-ALA fluorescence-guided surgery is effective for visualizing soft-tissue sarcoma?

Research shows that 5-Aminolevulinic Acid (5-ALA), the treatment under study in this trial, can help surgeons see soft-tissue sarcomas, a type of cancer, more clearly during surgery. 5-ALA travels through the bloodstream to the tumor and makes it glow under special lighting, helping surgeons distinguish between cancerous and healthy tissue. Early findings suggest this method can lead to more precise tumor removal, potentially improving surgical outcomes. Studies on similar techniques have shown promise in ensuring the removal of as much cancerous tissue as possible. Although more research is needed to confirm these benefits, early results are encouraging. ^{1 2 6 7 8}

Who Is on the Research Team?

Steven Thorpe, MD, FACS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals with soft tissue sarcoma, a type of cancer. Participants will take an oral agent before surgery to help the surgeon see the tumor better during removal.

Inclusion Criteria

I can swallow pills.

I can understand and am willing to sign a consent form.

I am 18 years old or older.

Exclusion Criteria

I do not have any form of porphyria.

I had cancer treatment or surgery less than 3 weeks ago.

I plan to use medications that may make my skin more sensitive to light.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants are administered 5-ALA orally 3-4 hours prior to surgery

1 day

1 visit (in-person)

Surgery

5-ALA fluorescence-guided surgery is performed to resect the soft-tissue sarcoma

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for oncologic outcomes and local recurrence free survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 5-Aminolevulinic Acid (5-ALA)

Trial Overview The study tests if using 5-Aminolevulinic acid (5-ALA) helps surgeons see and remove tumors more effectively by making them glow under special light during surgery.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

NX Development Corp

Industry Sponsor

Trials

4

Recruited

330+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07038278

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize ...

2. ar.iiarjournals.org ar.iiarjournals.org/content/44/3/963

The Effect of Photodynamic Therapy Using 5 ... This study examined whether photodynamic therapy using 5ALA (5-ALA PDT) could be used as a potential adjuvant therapy for bone and soft tissue sarcomas.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059315/

5-Aminolevulinic acid tumor paint and photodynamic ... 5-ALA tumor paint and PDT were successfully used on a human myxofibrosarcoma cell line (MUG-Myx1). Results from this study showed both selective ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024001315

In vitro modeling of recurrent Dermatofibrosarcoma ... This study aimed to evaluate the anti-tumor efficacy of 5-ALA PDT using an in vitro model derived from a recurrent DFSP patient.

5. clin.larvol.com clin.larvol.com/trial-detail/NCT07038278

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal, The sarcoma tumor ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846720307733

5-Aminolevulinic acid radiodynamic therapy for treatment ... Assessment of safety of 5-aminolevulinic acid–mediated photodynamic therapy ... Long-term clinical outcome in patients with high-grade soft tissue sarcoma ...

7. researchgate.net researchgate.net/publication/276493853_5-Aminolevulinic_Acid_5-ALA_Analysis_of_Preclinical_and_Safety_Literature

5-Aminolevulinic Acid (5-ALA): Analysis of Preclinical and ... Results: The safety of low-dose 5-ALA as a supplement has been demonstrated by animal and human studies. The results suggest that none of the ...

8. pathologyoutlines.com pathologyoutlines.com/topic/softtissuegrading.html

Grading - Soft tissue The combination of tumor differentiation (score 3), mitotic activity (score 2) and necrosis (score 0) sum to 5, which falls under grade 2 in the ...