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

NCT01898416 | Recruiting Phase 2

• 1 other identifier: TASMC-11-JB-558-CTIL
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.

  five years

Study Arms (1)

5-AminoLevulinicc Acid

EXPERIMENTAL

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.

Interventions

5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. DRUG

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.

5-AminoLevulinicc Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• Hepatic enzymes or bilirubin \> 2X upper limit of normal.
• Serum creatinine \> 2.5 x upper limit of normal.
• Suspected /documented metastatic disease.
• Active or uncontrolled infections.
• Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
• Use of other investigational agents \< 30 days prior to the study.
• Patients who are mentally or physically unable to comply with all aspects of the study.
• 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.
• Pregnant or lactating females.
• Known intolerance or allergy to 5-ALA
• Suspicious or documented acute or chronic porphyria

Sponsors & Collaborators

• michal roll: lead

Study Sites (2)

Tel Aviv sourasky medical center

Tel Aviv, Israel, 64239, Israel

RECRUITING

The Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239, Israel

RECRUITING

MeSH Terms

Interventions

Aminolevulinic Acid

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jacob Bickels, MD/PhD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Bickels, MD/PhD

CONTACT

+972-524266341; jACOBB@TLVMC.GOV.IL

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director research and development department

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 12, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

IL (2)