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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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
Sponsored by
michal roll
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel Aviv sourasky medical centerRecruiting
  • The Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

5-AminoLevulinicc Acid

Arm 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.

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2013
Last Updated
October 30, 2013
Sponsor
michal roll
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1. Study Identification

Unique Protocol Identification Number
NCT01898416
Brief Title
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Recruiting
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
michal roll

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-AminoLevulinicc Acid
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
Description
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.
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Bickels, MD/PhD
Phone
+972-524266341
Email
jACOBB@TLVMC.GOV.IL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Bickels, MD/PhD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv sourasky medical center
City
Tel AVIV
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Bickels, MD/PhD
Phone
+972-524266341
Email
JACOBB@TLVMC.GOV.IL
Facility Name
The Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Bickels, MD/PhD
Phone
+972-524266341
Email
jacobb@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Jacob Bickels, MD/PhD

12. IPD Sharing Statement

Learn more about this trial

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

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