Trial Outcomes & Findings for Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer (NCT NCT03727061)
NCT ID: NCT03727061
Last Updated: 2025-03-11
Results Overview
The frequency of toxicities will be tabulated by max grade of any Adverse Events experience by a patient across dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Arm A(Porfimer Sodium, I-PDT
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm A(Porfimer Sodium, I-PDT
n=5 Participants
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
The frequency of toxicities will be tabulated by max grade of any Adverse Events experience by a patient across dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Outcome measures
| Measure |
Arm A(Porfimer Sodium, I-PDT
n=5 Participants
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies
|
|---|---|
|
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
grade 1
|
0 Participants
|
|
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
grade 2
|
1 Participants
|
|
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
grade 3
|
4 Participants
|
|
Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
grade 4
|
0 Participants
|
Adverse Events
Arm A(Porfimer Sodium, I-PDT
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A(Porfimer Sodium, I-PDT
n=5 participants at risk
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies
|
|---|---|
|
General disorders
General disorders and administration site conditions - Other, specify
|
40.0%
2/5 • Number of events 2 • Routine visits at 10-12 weeks and until 8 months
|
|
Social circumstances
Social circumstances - Other, specify
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
Other adverse events
| Measure |
Arm A(Porfimer Sodium, I-PDT
n=5 participants at risk
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Nivolumab: Immunotherapy - Standard of care
Porfimer Sodium: Given IV
Interstitial Illumination Photodynamic Therapy: Undergo I-PDT
Quality of Life Assessment: Ancillary Studies
|
|---|---|
|
Eye disorders
Photophobia
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Eye disorders
Vision decreased
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 4 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Edema face
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Facial pain
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Fever
|
40.0%
2/5 • Number of events 2 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
General disorders
Localized edema
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Injury, poisoning and procedural complications
Burn
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
20.0%
1/5 • Number of events 3 • Routine visits at 10-12 weeks and until 8 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Investigations
Weight loss
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Nervous system disorders
Amnesia
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Nervous system disorders
Paresthesia
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Nervous system disorders
Vasovagal reaction
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Psychiatric disorders
Confusion
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Routine visits at 10-12 weeks and until 8 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
40.0%
2/5 • Number of events 2 • Routine visits at 10-12 weeks and until 8 months
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Compressive Cancer Center
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place