Trial Outcomes & Findings for Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer (NCT NCT02068157)
NCT ID: NCT02068157
Last Updated: 2017-10-11
Results Overview
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
TERMINATED
PHASE2
3 participants
Up to 12 months
2017-10-11
Participant Flow
Participant milestones
| Measure |
Treatment (Porfimer Sodium, Image-guided I-PDT)
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Porfimer Sodium, Image-guided I-PDT)
n=3 Participants
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All treated and eligible patients
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Porfimer Sodium, Image-guided I-PDT)
n=3 Participants
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV
|
|---|---|
|
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
|
33 percentage of participants
Interval 1.0 to 91.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The published assay could not be validated in murine samples. As such, no human samples were analyzed.
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Porfimer Sodium, Image-guided I-PDT)
Serious adverse events
| Measure |
Treatment (Porfimer Sodium, Image-guided I-PDT)
n=3 participants at risk
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV
|
|---|---|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 35
|
Other adverse events
| Measure |
Treatment (Porfimer Sodium, Image-guided I-PDT)
n=3 participants at risk
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo image-guided I-PDT
Porfimer Sodium: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 23
|
|
Ear and labyrinth disorders
Ear pain
|
33.3%
1/3 • Number of events 9
|
|
Eye disorders
Eye irritation
|
33.3%
1/3 • Number of events 6
|
|
Eye disorders
Eye swelling
|
33.3%
1/3 • Number of events 5
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 26
|
|
General disorders
Injection site pain
|
33.3%
1/3 • Number of events 9
|
|
Injury, poisoning and procedural complications
Sunburn
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
1/3 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
33.3%
1/3 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 36
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place