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.

Who is this study for? Patients with Desmoid Tumor
What treatments are being studied? 5-AMINOLEVULINIC ACID
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient has a resectable histologically confirmed desmoid tumor.

• Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.

• Age > 18 years

• Signed informed consent prior to patient recruitment. -

Locations
Other Locations
Israel
Tel Aviv sourasky medical center
Recruiting
Tel Aviv
The Aviv Sourasky Medical Center
Recruiting
Tel Aviv
Contact Information
Primary
Jacob Bickels, MD/PhD
jACOBB@TLVMC.GOV.IL
+972-524266341
Time Frame
Start Date: June 2013
Estimated Completion Date: December 2026
Participants
Target number of participants: 140
Treatments
Experimental: 5-AminoLevulinicc Acid
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.
Related Therapeutic Areas
Sponsors
Leads: michal roll

This content was sourced from clinicaltrials.gov

Similar Clinical Trials