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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Resection; 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
• Intervention / Treatment: Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacob Bickels, MD/PhD; Phone Number: +972-524266341; Email: jacobb@tlvmc.gov.il

Study Locations

• Israel
  • Tel AVIV, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Jacob Bickels, MD/PhD; Phone Number: +972-524266341; Email: jacobb@tlvmc.gov.il
  • Tel Aviv, Israel, 64239
    • Recruiting
    • The Aviv Sourasky Medical Center
    • Contact: Jacob Bickels, MD/PhD; Phone Number: +972-524266341; Email: jacobb@tlvmc.gov.il
    • Principal Investigator: Jacob Bickels, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: michal roll
• Investigators: Principal Investigator: Jacob Bickels, MD/PhD, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Fibromatosis, Aggressive; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: TASMC-11-JB-558-CTIL