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Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00243490
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Taiwan University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jui-Chang Tsai, M.D. Ph.D.
Principal Investigator Affiliation National Taiwan University College of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Withdrawn
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Anaplastic Ependymoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Taiwan University Hospital, Taipei, Taiwan

Status

Address

National Taiwan University Hospital

Taipei, ,