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

michal roll

Status and phase: Enrolling; Phase 2

Conditions: Surgical Resection; Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After; The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an

Treatments: Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.

Study type: Interventional

Funder types: Other

Identifiers

NCT01898416

TASMC-11-JB-558-CTIL

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

5-AminoLevulinicc Acid

Experimental group

Description:

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.

Treatment:

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