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

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00530088
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 108
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.

PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: porfimer sodium; Drug: Photdynamic Therapy (PDT)	N/A

Detailed Description

OBJECTIVES:

• To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.

• To identify the local toxicity of this treatment in these patients.

OUTLINE: 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. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.

After completion of study therapy, patients are followed for 1-2 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: porfimer sodium; IV; Drug: Photdynamic Therapy (PDT)

Outcome Measures

Primary Outcome Measures

1. Response [2 years]

   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.

2. Local Toxicity [30 days]

   Number of patients with an adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Biopsy confirmed oral cavity or larynx lesion with mild-to-severe dysplasia OR in situ or stage I (T1, N0) squamous cell carcinoma of the oral cavity or larynx

• Recurrent disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• WBC ≥ 4,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Total bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 2.0 mg/dL

• Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

• SGOT ≤ 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must practice effective contraception

• No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

• Any type of prior therapy allowed

• More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001

Sponsors and Collaborators

• Roswell Park Cancer Institute

Investigators

• Principal Investigator: Nestor R. Rigual, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00530088
• Other Study ID Numbers: CDR0000564841; RPCI-RPC-01-08
• First Posted: Sep 17, 2007
• Last Update Posted: Jul 4, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Roswell Park Cancer Institute: recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage 0 laryngeal cancer; stage 0 lip and oral cavity cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Dihematoporphyrin Ether; Trioxsalen

Study Results

Participant Flow

Arm/Group Title	Porfimer Sodium
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
Period Title: Overall Study
STARTED	30
COMPLETED	20
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Porfimer Sodium
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 Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.8 (10.1)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 63.3%
>=65 years	11 36.7%
Sex: Female, Male (Count of Participants)
Female	8 26.7%
Male	22 73.3%

Outcome Measures

1. Primary Outcome

Title	Response
Description	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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Porfimer Sodium
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
Measure Participants	29
Number (95% Confidence Interval) [percentage of participants]	3.5 11.7%

2. Primary Outcome

Title	Local Toxicity
Description	Number of patients with an adverse event
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Porfimer Sodium
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
Measure Participants	30
Number [participants]	29 96.7%

Adverse Events

Arm/Group Title	Porfimer Sodium
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
All Cause Mortality
	Porfimer Sodium
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Porfimer Sodium
	Affected / at Risk (%)	# Events
Total	3/30 (10%)
General disorders
Non-cardiac chest pain	1/30 (3.3%)	1
Pain	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Porfimer Sodium
	Affected / at Risk (%)	# Events
Total	29/30 (96.7%)
Gastrointestinal disorders
Cheilitis	1/30 (3.3%)	1
Constipation	2/30 (6.7%)	2
Dysphagia	1/30 (3.3%)	1
Lip oedema	1/30 (3.3%)	1
Odynophagia	2/30 (6.7%)	2
Oedema mouth	2/30 (6.7%)	2
Oral pain	4/30 (13.3%)	5
Oral pruritus	1/30 (3.3%)	1
General disorders
Face oedema	2/30 (6.7%)	2
Oedema	14/30 (46.7%)	15
Pain	16/30 (53.3%)	18
Infections and infestations
Herpes virus infection	1/30 (3.3%)	1
Sinusitis	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Sunburn	18/30 (60%)	21
Urinary retention postoperative	1/30 (3.3%)	1
Investigations
Weight decreased	5/30 (16.7%)	5
Metabolism and nutrition disorders
Decreased appetite	1/30 (3.3%)	1
Nervous system disorders
Dizziness	1/30 (3.3%)	1
Dysgeusia	1/30 (3.3%)	1
Headache	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/30 (3.3%)	1
Dysphonia	5/30 (16.7%)	5
Epistaxis	1/30 (3.3%)	1
Laryngeal oedema	2/30 (6.7%)	2
Pharyngolaryngeal pain	2/30 (6.7%)	2
Skin and subcutaneous tissue disorders
Dry skin	1/30 (3.3%)	1
Erythema	6/30 (20%)	6
Photosensitivity reaction	1/30 (3.3%)	1
Pruritus	1/30 (3.3%)	1

Limitations/Caveats

Due to the study's early termination, as a result of new competing studies, target accrual was not reached.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.