Using 5-ALA to prevent tumor recurrence in desmoid tumor patients

A PHASE 2, SINGLE CENTRE, SINGLE ARM STUDY TO DETERMINE THE EFFICACY AND SAFETY OF 5- ALA POHOTODYNAMIC THERAPY AS ADJUVANT THERAPY AFTER SURGICAL DISSECTION IN PATIENTS WITH DESMOID TUMORS.

This study is testing if taking a medication called 5-ALA before surgery and using red light therapy afterward can help prevent desmoid tumors from coming back in patients who have had surgery to remove them.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tel-Aviv Sourasky Medical Center (Government)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Tel Aviv, Israel and 1 other locations)
• Trial ID: NCT01898416 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of oral 5-ALA administration followed by intraoperative phototherapy using red light laser as an adjuvant treatment for patients with desmoid tumors after surgical resection. The primary goal is to assess the rate of local tumor recurrence over three years. Additionally, the study aims to ensure the safety of 5-ALA administration in this patient population. Participants will be monitored for any adverse effects and overall clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with resectable, histologically confirmed desmoid tumors, including those previously treated.

Not a fit: Patients with metastatic disease, uncontrolled infections, or serious medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rate of local tumor recurrence in patients with desmoid tumors.

How similar studies have performed: While the specific combination of 5-ALA and phototherapy is novel, similar approaches in photodynamic therapy have shown promise in other tumor types.

Eligibility criteria

Inclusion Criteria:

1. Patient has a resectable histologically confirmed desmoid tumor.
2. Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
3. Age \> 18 years
4. Signed informed consent prior to patient recruitment. -

Exclusion Criteria:

1. Hepatic enzymes or bilirubin \> 2X upper limit of normal.
2. Serum creatinine \> 2.5 x upper limit of normal.
3. Suspected /documented metastatic disease.
4. Active or uncontrolled infections.
5. Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
6. Use of other investigational agents \< 30 days prior to the study.
7. Patients who are mentally or physically unable to comply with all aspects of the study.
8. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
9. Pregnant or lactating females.
10. Known intolerance or allergy to 5-ALA
11. Suspicious or documented acute or chronic porphyria

Where this trial is running

Tel Aviv, Israel and 1 other locations

• Tel Aviv sourasky medical center — Tel Aviv, Israel, Israel (Recruiting)
• The Aviv Sourasky Medical Center — Tel Aviv, Israel, Israel (Recruiting)

Study contacts

• Principal investigator: Jacob Bickels, MD/PhD — Tel-Aviv Sourasky Medical Center
• Study coordinator: Jacob Bickels, MD/PhD

Conditions The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an; Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After; Surgical Resection