Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

January 11, 2010 updated by: National Taiwan University Hospital

Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Steroids are withdrawn 2-3 days prior to sensitization.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.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Hospital inpatients over the age of 20 years and under the age of 75 years, male or female.
  2. 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.
  3. Suitable for gross total resection on the basis of imaging studies from doctor's point of view
  4. Karnofsky Performance Scale (KPS) ≥ 60 for newly diagnosed tumor
  5. KPS ≥ 70 for recurrent tumor
  6. Life expectancy at least 3 months
  7. Not pregnant or lactating.
  8. Patients willing to participate in the trial and sign written informed consent

Exclusion Criteria:

  1. Subject is known, suspected or has history of intolerance or allergy to porphyrin.
  2. Renal dysfunction (serum creatinine > 1.5 mg/dL)
  3. PT/PTT greater than 1.5 times upper limit of normal (ULN)
  4. Bilirubin and liver function tests (LFTs) greater than 2 times ULN
  5. Alkaline phosphatase greater than 3 times ULN
  6. γ-GT greater than 3 times ULN
  7. Severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV).
  8. Febrile illness and total leukocyte count < 3,000/µL and/or platelet count < 80,000/µL.
  9. 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.
  10. Organ transplant.
  11. 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.
  12. Significant alcohol, drug or medication abuse as judged by the investigator.
  13. History of treatment with any investigational drug within four weeks before the start of study.
  14. Tumors located within the cerebellum or brainstem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jui-Chang Tsai, M.D. Ph.D., National Taiwan University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

January 1, 2009

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33MD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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