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Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

Primary Purpose

Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas

Status
Withdrawn
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Intracranial Tumors focused on measuring Photodynamic therapy, Malignant glioma, Photosan

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospital inpatients over the age of 20 years and under the age of 75 years, male or female. Patients who are diagnosed as primary or recurrent malignant intracranial tumors (Grade III or Grade IV gliomas defined by the World Health Organization [WHO] classification), including anaplastic astrocytomas, anaplastic oligodendrogliomas, anaplastic ependymal tumors or glioblastoma multiforme. Suitable for gross total resection on the basis of imaging studies from doctor's point of view Karnofsky Performance Scale (KPS) ≥ 60 for newly diagnosed tumor KPS ≥ 70 for recurrent tumor Life expectancy at least 3 months Not pregnant or lactating. Patients willing to participate in the trial and sign written informed consent Exclusion Criteria: Subject is known, suspected or has history of intolerance or allergy to porphyrin. Renal dysfunction (serum creatinine > 1.5 mg/dL) PT/PTT greater than 1.5 times upper limit of normal (ULN) Bilirubin and liver function tests (LFTs) greater than 2 times ULN Alkaline phosphatase greater than 3 times ULN γ-GT greater than 3 times ULN Severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV). Febrile illness and total leukocyte count < 3,000/µL and/or platelet count < 80,000/µL. Implantable electronic medical device such as a pacemaker, life-sustaining electronic medical device such as an artificial heart-lung machine, contact type electronic medical device such as an electrocardiograph, others such as an artificial middle ear, artificial inner ear, metal artificial cardiac valve and gold haemostatic clip. Organ transplant. History or evidence of severe illness or any other condition which would make the patient, in the opinion of the investigator unsuitable for the study. Significant alcohol, drug or medication abuse as judged by the investigator. History of treatment with any investigational drug within four weeks before the start of study. Tumors located within the cerebellum or brainstem

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

The addition of photodynamic therapy to standard brain tumor treatments will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant intracranial tumors.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2005
Last Updated
January 11, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00243490
Brief Title
Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Official Title
Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
Primary Objective: The primary objective is to evaluate the efficacy of photodynamic therapy in the treatment of malignant intracranial tumors. Secondary Objective: The secondary objective is to evaluate the safety of photodynamic therapy in the treatment of malignant intracranial tumors.
Detailed Description
After passing Photosan® allergic test, the patients will be injected intravenously with Photosan® (2mg/kg) during 15~30 minutes, 48 hours prior to a standard craniotomy. Precautions are taken not to expose the patient in the operating room to direct room or operating light and to shield the skin of the flap during operation. Steroids are withdrawn 2-3 days prior to sensitization. After maximal resection, the surface of the tumor bed will be calculated and the generated cavity kept with a balloon containing intralipid (0.1%) or saline and/or artificial spinal fluid in it. A fiber with a spherical diffuser will be centered in the cavity and the surface irradiated with red (625~635nm) Halogen light. The dose of light irradiation depends on individual condition of the patient, usually with an energy density of 100 J/cm2 at a power density of 500 mW/cm2 to 600 mW/cm2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Anaplastic Ependymoma
Keywords
Photodynamic therapy, Malignant glioma, Photosan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
Primary Outcome Measure Information:
Title
The addition of photodynamic therapy to standard brain tumor treatments will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant intracranial tumors.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital inpatients over the age of 20 years and under the age of 75 years, male or female. Patients who are diagnosed as primary or recurrent malignant intracranial tumors (Grade III or Grade IV gliomas defined by the World Health Organization [WHO] classification), including anaplastic astrocytomas, anaplastic oligodendrogliomas, anaplastic ependymal tumors or glioblastoma multiforme. Suitable for gross total resection on the basis of imaging studies from doctor's point of view Karnofsky Performance Scale (KPS) ≥ 60 for newly diagnosed tumor KPS ≥ 70 for recurrent tumor Life expectancy at least 3 months Not pregnant or lactating. Patients willing to participate in the trial and sign written informed consent Exclusion Criteria: Subject is known, suspected or has history of intolerance or allergy to porphyrin. Renal dysfunction (serum creatinine > 1.5 mg/dL) PT/PTT greater than 1.5 times upper limit of normal (ULN) Bilirubin and liver function tests (LFTs) greater than 2 times ULN Alkaline phosphatase greater than 3 times ULN γ-GT greater than 3 times ULN Severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV). Febrile illness and total leukocyte count < 3,000/µL and/or platelet count < 80,000/µL. Implantable electronic medical device such as a pacemaker, life-sustaining electronic medical device such as an artificial heart-lung machine, contact type electronic medical device such as an electrocardiograph, others such as an artificial middle ear, artificial inner ear, metal artificial cardiac valve and gold haemostatic clip. Organ transplant. History or evidence of severe illness or any other condition which would make the patient, in the opinion of the investigator unsuitable for the study. Significant alcohol, drug or medication abuse as judged by the investigator. History of treatment with any investigational drug within four weeks before the start of study. Tumors located within the cerebellum or brainstem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jui-Chang Tsai, M.D. Ph.D.
Organizational Affiliation
National Taiwan University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

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