Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

NCT00243490 | Withdrawn Phase 2

• 1 other identifier: 33MD01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Intracranial Tumors; Glioblastoma Multiforme; Anaplastic Astrocytomas; Anaplastic Oligodendrogliomas; Anaplastic Ependymoma

Keywords

Photodynamic therapy; Malignant glioma; Photosan

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M PROCEDURE

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Ependymoma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jui-Chang Tsai, M.D. Ph.D.

  National Taiwan University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 24, 2005
• Study Completion: January 1, 2009
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

TW (1)