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

Phase 2

Recruiting

• 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
• Interventions: Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.

• Registration Number: NCT01898416
• Lead Sponsor: michal roll

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31
• Primary Completion: 2023-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5-AminoLevulinicc Acid	5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.	consists of 60mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia and surgical tumor resection. 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 the case of positive margins (for tumor presence), a second surgical intervention followed by second 60mg/kg 5-ALA administration will be performed.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.	five years	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.

Trial Locations

Locations (2)

Tel Aviv sourasky medical center; 🇮🇱 Tel AVIV, Israel

The Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel