Malignant Intracranial TumorsPhase 2NCT00243490
Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
A Phase 2 study testing Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M in people with Malignant Intracranial Tumors and Glioblastoma Multiforme, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas
- What is being tested?
- Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- Start not givento Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Anaplastic Ependymoma
- Being tested
- Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
- Keywords
- Photodynamic therapy, Malignant glioma, Photosan
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Ependymoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122MProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study completionJan 2009
Why it stopped: The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Intracranial TumorsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jui-Chang Tsai, M.D. Ph.D., Principal investigator, National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243490
- Sponsor's protocol ID
- 33MD01
- Status last verified
- Jan 2010
- First submitted
- 20 Oct 2005
- Last updated
- 12 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00243490
- Acronym / sponsor ID
- 33MD01
- Conditions
- Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Anaplastic Ependymoma
- Keywords
- Photodynamic therapy, Malignant glioma, Photosan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study completion
- Jan 2009
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jui-Chang Tsai, M.D. Ph.D. principal investigator
National Taiwan University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M in people with Malignant Intracranial Tumors and Glioblastoma Multiforme, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.