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This study has been withdrawn prior to enrollment.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:
National Taiwan University Hospital
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
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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 |
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 Steroids are withdrawn 2-3 days prior to sensitization.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
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 Ependymoma Glioblastoma Oligodendroglioma Brain Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013