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Trial record 33 of 6995 for:    Oral Cancer | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT00530088
Recruitment Status : Terminated (new competing studies)
First Posted : September 17, 2007
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Drug: porfimer sodium
Drug: Photdynamic Therapy (PDT)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Porfimer Sodium
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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

Period Title: Overall Study
Started 30
Completed 20
Not Completed 10
Reason Not Completed
Disease Progression             4
Physician Decision             4
Other Not Specified             2
Arm/Group Title Porfimer Sodium
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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 Number of Baseline Participants 30
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
60.8  (10.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  63.3%
>=65 years
11
  36.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
1.Primary Outcome
Title Response
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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.

Time Frame 2 years
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Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Porfimer Sodium
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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 Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.5
(0 to 10)
2.Primary Outcome
Title Local Toxicity
Hide Description Number of patients with an adverse event
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Porfimer Sodium
Hide Arm/Group Description:

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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Porfimer Sodium
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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

All-Cause Mortality
Porfimer Sodium
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Porfimer Sodium
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
General disorders   
Non-cardiac chest pain   1/30 (3.33%)  1
Pain   1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration   1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Porfimer Sodium
Affected / at Risk (%) # Events
Total   29/30 (96.67%)    
Gastrointestinal disorders   
Cheilitis   1/30 (3.33%)  1
Constipation   2/30 (6.67%)  2
Dysphagia   1/30 (3.33%)  1
Lip oedema   1/30 (3.33%)  1
Odynophagia   2/30 (6.67%)  2
Oedema mouth   2/30 (6.67%)  2
Oral pain   4/30 (13.33%)  5
Oral pruritus   1/30 (3.33%)  1
General disorders   
Face oedema   2/30 (6.67%)  2
Oedema   14/30 (46.67%)  15
Pain   16/30 (53.33%)  18
Infections and infestations   
Herpes virus infection   1/30 (3.33%)  1
Sinusitis   1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Sunburn   18/30 (60.00%)  21
Urinary retention postoperative   1/30 (3.33%)  1
Investigations   
Weight decreased   5/30 (16.67%)  5
Metabolism and nutrition disorders   
Decreased appetite   1/30 (3.33%)  1
Nervous system disorders   
Dizziness   1/30 (3.33%)  1
Dysgeusia   1/30 (3.33%)  1
Headache   1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   1/30 (3.33%)  1
Dysphonia   5/30 (16.67%)  5
Epistaxis   1/30 (3.33%)  1
Laryngeal oedema   2/30 (6.67%)  2
Pharyngolaryngeal pain   2/30 (6.67%)  2
Skin and subcutaneous tissue disorders   
Dry skin   1/30 (3.33%)  1
Erythema   6/30 (20.00%)  6
Photosensitivity reaction   1/30 (3.33%)  1
Pruritus   1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Due to the study's early termination, as a result of new competing studies, target accrual was not reached.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00530088     History of Changes
Other Study ID Numbers: CDR0000564841
RPCI-RPC-01-08 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: January 29, 2014
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014