Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.

Source null

→

secondary · POSTED

To obtain preliminary data toward determining whether this combination results in higher remission rate when compared to historical data.

Study closed before three year period was completed. Only one participant was enrolled.

→

secondary · POSTED

To further explore and report progression-free survival and overall survival for three years post PDT treatment.

Study closed before three year period was completed. Only one participant was enrolled.

→

secondary · POSTED

To measure complete response, partial response, stable disease or progressive disease using the response assessment for Neuro-Oncology (RANO) criteria with the follow-up medical imaging, which specifically incorporates volumetric measurements of brain tumor enhancement and clinical measures of neurological decline and to compare these outcomes to historical controls.

Participant lost to followup before secondary outcome was assessed.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id: NCT01966809
trial label: Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0000
source section id
NCT01966809-om-0000
source outcome index
0
endpoint
Six Month Relapse-free Survival (RFS).
endpoint definition
Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.
time origin
Six months from PDT
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0001
source section id
NCT01966809-om-0001
source outcome index
1
endpoint
Remission Rate.
endpoint definition
To obtain preliminary data toward determining whether this combination results in higher remission rate when compared to historical data.
time origin
Three years from PDT
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Study closed before three year period was completed. Only one participant was enrolled.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0002
source section id
NCT01966809-om-0002
source outcome index
2
endpoint
Progression-free Survival and Overall Survival.
endpoint definition
To further explore and report progression-free survival and overall survival for three years post PDT treatment.
time origin
Three years from PDT
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Study closed before three year period was completed. Only one participant was enrolled.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0003
source section id
NCT01966809-om-0003
source outcome index
3
endpoint
Tumor Response.
endpoint definition
To measure complete response, partial response, stable disease or progressive disease using the response assessment for Neuro-Oncology (RANO) criteria with the follow-up medical imaging, which specifically incorporates volumetric measurements of brain tumor enhancement and clinical measures of neurological decline and to compare these outcomes to historical controls.
time origin
Six months from PDT
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participant lost to followup before secondary outcome was assessed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0000
arm key
OG000
arm label
Photofrin Photodynamic Therapy.
regimen
Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01966809-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0001
arm key
OG000
arm label
Photofrin Photodynamic Therapy.
regimen
Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01966809-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0002
arm key
OG000
arm label
Photofrin Photodynamic Therapy.
regimen
Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01966809-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
outcome key
om-0003
arm key
OG000
arm label
Photofrin Photodynamic Therapy.
regimen
Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01966809-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT01966809
harm key
EG000
source section id
NCT01966809-ae
event group key
EG000
event group label
Photofrin Photodynamic Therapy.
serious affected
1
serious at risk
1
other affected
0
other at risk
1
frequency threshold
0
collection period
6 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice