Trial Outcomes & Findings for Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat (NCT NCT00530088)

NCT ID: NCT00530088

Last Updated: 2014-07-04

Results Overview

Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2014-07-04

Participant Flow

Participant milestones

Measure	Porfimer Sodium Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Porfimer Sodium Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Overall Study Disease Progression	4
Overall Study Physician Decision	4
Overall Study Other Not Specified	2

Baseline Characteristics

Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat

Baseline characteristics by cohort

Measure	Porfimer Sodium n=30 Participants Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Age, Continuous	60.8 years STANDARD_DEVIATION 10.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All treated and eligible patients

Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.

9.23 No Response. All responses less than a Partial Response are considered as No Response.

9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.

Outcome measures

Measure	Porfimer Sodium n=29 Participants Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Response	3.5 percentage of participants Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 30 days

Population: All treated and eligible patients

Number of patients with an adverse event

Outcome measures

Measure	Porfimer Sodium n=30 Participants Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Local Toxicity	29 participants

Adverse Events

Porfimer Sodium

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Porfimer Sodium n=30 participants at risk Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
General disorders Non-cardiac chest pain	3.3% 1/30 • Number of events 1
General disorders Pain	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.3% 1/30 • Number of events 1

Other adverse events

Measure	Porfimer Sodium n=30 participants at risk Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
Gastrointestinal disorders Cheilitis	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Constipation	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Dysphagia	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Lip oedema	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Odynophagia	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Oedema mouth	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Oral pain	13.3% 4/30 • Number of events 5
Gastrointestinal disorders Oral pruritus	3.3% 1/30 • Number of events 1
General disorders Face oedema	6.7% 2/30 • Number of events 2
General disorders Oedema	46.7% 14/30 • Number of events 15
General disorders Pain	53.3% 16/30 • Number of events 18
Infections and infestations Herpes virus infection	3.3% 1/30 • Number of events 1
Infections and infestations Sinusitis	3.3% 1/30 • Number of events 1
Injury, poisoning and procedural complications Sunburn	60.0% 18/30 • Number of events 21
Injury, poisoning and procedural complications Urinary retention postoperative	3.3% 1/30 • Number of events 1
Investigations Weight decreased	16.7% 5/30 • Number of events 5
Metabolism and nutrition disorders Decreased appetite	3.3% 1/30 • Number of events 1
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1
Nervous system disorders Dysgeusia	3.3% 1/30 • Number of events 1
Nervous system disorders Headache	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dysphonia	16.7% 5/30 • Number of events 5
Respiratory, thoracic and mediastinal disorders Epistaxis	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	6.7% 2/30 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.7% 2/30 • Number of events 2
Skin and subcutaneous tissue disorders Dry skin	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Erythema	20.0% 6/30 • Number of events 6
Skin and subcutaneous tissue disorders Photosensitivity reaction	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

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