Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors

Surgical Resection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01898416
• Other study ID #: TASMC-11-JB-558-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: June 26, 2013
• Last updated: October 30, 2013
• Start date: June 2013
• Est. completion date: December 2026

Study information

• Verified date: October 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jacob Bickels, MD/PhD
• Phone: +972-524266341
• Email: jACOBB[@]TLVMC.GOV.IL
• Is FDA regulated: No
• Health authority: Ministry Of Health: Israel
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
60 mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia. Red light laser given by a Dye laser system, wave length of 635nm, in s dose of 150J/cm for 2000 seconds (33 minutes) will be given to tumor bed. In case of positive margins a second operation and 5-ALA administration or irradiation will be given.

Locations

Country	Name	City	State
Israel	Tel Aviv sourasky medical center	Tel AVIV
Israel	The Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
michal roll

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is a binary variable where each patient is classified as a recurrence or a not recurrence case and will be determined by calculating the proportion of recurrence versus non recurrence rates		three years	Yes
Secondary	To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.	Data from all subjects who receive any study drug will be included in the safety analyses. The severity of the toxicities will be graded according to the NCI CTCAE whenever possible. Adverse events will be summarized by worst NCI CTC grade. Adverse events classified as NCI CTCAE Grade 3 or Grade 4, study-drug-related events, and serious adverse events will be summarized separately. Laboratory data will be graded according to NCI CTCAE severity grade.	five years	Yes