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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

This study is currently recruiting participants.
Verified October 2013 by michal roll, Tel-Aviv Sourasky Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01898416
First Posted: July 12, 2013
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center
June 26, 2013
July 12, 2013
October 31, 2013
June 2013
December 2023   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01898416 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
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.

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.
Intervention: Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2026
December 2023   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jacob Bickels, MD/PhD +972-524266341 jACOBB@TLVMC.GOV.IL
Israel
 
 
NCT01898416
TASMC-11-JB-558-CTIL
No
Not Provided
Not Provided
michal roll, Tel-Aviv Sourasky Medical Center
michal roll
Not Provided
Principal Investigator: Jacob Bickels, MD/PhD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP