Trial Outcomes & Findings for Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers (NCT NCT01415986)

NCT ID: NCT01415986

Last Updated: 2012-12-03

Results Overview

Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment
• Results posted on: 2012-12-03

Participant Flow

Participant milestones

Measure	Group 1 Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Group 1 Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Interstitial Photodynamic Therapy (PDT) With Temoporfin for Advanced Head and Neck Cancers

Baseline characteristics by cohort

Measure	Group 1 n=1 Participants Interstitial Photodynamic Therapy (I-PDT)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment

Population: No data was collected because the participant was lost to follow up.

Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.

Population: No data was collected because the participant was lost to follow up.

The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=1 participants at risk Interstitial Photodynamic Therapy (I-PDT)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Gal Shafirstein, D.Sc.

Roswell Park Cancer Institute

Phone: 716-845-4025

Email: Gal.Shafirstein@RoswellPark.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place