Trial Outcomes & Findings for Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas (NCT NCT01966809)
NCT ID: NCT01966809
Last Updated: 2019-08-20
Results Overview
Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.
TERMINATED
PHASE2
1 participants
Six months from PDT
2019-08-20
Participant Flow
Participant milestones
| Measure |
Photofrin Photodynamic Therapy.
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.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Photofrin Photodynamic Therapy.
n=1 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=1 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=1 Participants
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Age, Categorical
>=65 years
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1 Participants
n=1 Participants
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Sex: Female, Male
Female
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1 Participants
n=1 Participants
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Sex: Female, Male
Male
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0 Participants
n=1 Participants
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PRIMARY outcome
Timeframe: Six months from PDTRelapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.
Outcome measures
| Measure |
Photofrin Photodynamic Therapy.
n=1 Participants
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.
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|---|---|
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Six Month Relapse-free Survival (RFS).
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0 participants
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SECONDARY outcome
Timeframe: Three years from PDTPopulation: Study closed before three year period was completed. Only one participant was enrolled.
To obtain preliminary data toward determining whether this combination results in higher remission rate when compared to historical data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three years from PDTPopulation: Study closed before three year period was completed. Only one participant was enrolled.
To further explore and report progression-free survival and overall survival for three years post PDT treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Six months from PDTPopulation: Participant lost to followup before secondary outcome was assessed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Photofrin Photodynamic Therapy.
Serious adverse events
| Measure |
Photofrin Photodynamic Therapy.
n=1 participants at risk
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.
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Nervous system disorders
Altered mental status
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100.0%
1/1 • Number of events 1 • 6 months
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place