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. (see Contacts and Locations)
Verified October 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01898416
First received: June 26, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
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.
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate. [ Time Frame: five years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 140
Study Start Date: June 2013
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898416

Contacts
Contact: Jacob Bickels, MD/PhD +972-524266341 jACOBB@TLVMC.GOV.IL

Locations
Israel
The Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Jacob Bickels, MD/PhD    +972-524266341    jacobb@tlvmc.gov.il   
Principal Investigator: Jacob Bickels, MD/PhD         
Tel Aviv sourasky medical center Recruiting
Tel AVIV, Israel, 64239
Contact: Jacob Bickels, MD/PhD    +972-524266341    JACOBB@TLVMC.GOV.IL   
Sponsors and Collaborators
michal roll
Investigators
Principal Investigator: Jacob Bickels, MD/PhD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: michal roll, Director research and development department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01898416     History of Changes
Other Study ID Numbers: TASMC-11-JB-558-CTIL
Study First Received: June 26, 2013
Last Updated: October 30, 2013
Health Authority: Ministry Of Health: Israel

Additional relevant MeSH terms:
Neoplasms
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014