A Phase 2 interventional study of 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. in 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 and Surgical Resection, sponsored by michal roll. Recruiting at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-31.
Sponsored by michal roll · Phase 2, Interventional, and Treatment
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.
34 studies on the registry are indexed under Fibromatosis, Aggressive; 4 are open to participants now.
This study's planned enrollment of 140 is above the median of 28 across 23 interventional studies indexed under Fibromatosis, Aggressive.
Browse Fibromatosis, Aggressive studies →michal roll is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
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
Time frame: three years
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.
Time frame: five years
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