Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors - Full Text View

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00243490

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 Steroids are withdrawn 2-3 days prior to sensitization.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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243490

Contacts

Contact: Jui-Chang Tsai, M.D. Ph.D.

886-2-23123456 ext 5422

jctsai@ha.mc.ntu.edu.tw

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

Study ID Numbers:	33MD01
Study First Received:	October 20, 2005
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00243490 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Photodynamic therapy
Malignant glioma
Photosan

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Ependymoma
Brain Neoplasms

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Oligodendroglioma
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009