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

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.

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Key information

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tel Aviv sourasky medical center, Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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. -

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Secondary outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Bickels, MD/PhD

CONTACT

[email protected]

+972-524266341

Sponsors and collaborators

Lead sponsor

michal roll

Other Gov

Registry information

Official study title

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.

Important dates

Study start: 2013
Primary completion: 2023
Study completion: 2026
First posted: Jul 12, 2013
Registry last updated: Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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