Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

This study has been withdrawn prior to enrollment.
(The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00243490
First received: October 20, 2005
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.

Condition Intervention Phase
Malignant Intracranial Tumors
Glioblastoma Multiforme
Anaplastic Astrocytomas
Anaplastic Oligodendrogliomas
Anaplastic Ependymoma
Procedure: Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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.

Estimated Enrollment: 5
Estimated Study Completion Date: January 2009
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 Steroids are withdrawn 2-3 days prior to sensitization.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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00243490

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jui-Chang Tsai, M.D. Ph.D. National Taiwan University College of Medicine
  More Information

No publications provided

Responsible Party: Jui-Chang Tsai, M.D. Ph.D., National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00243490     History of Changes
Other Study ID Numbers: 33MD01
Study First Received: October 20, 2005
Last Updated: January 11, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Photodynamic therapy
Malignant glioma
Photosan

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Ependymoma
Glioblastoma
Oligodendroglioma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 20, 2014