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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00530088
• Other study ID #: CDR0000564841
• Secondary ID: RPCI-RPC-01-08
• Status: Terminated
• Phase: N/A
• First received: September 13, 2007
• Last updated: June 3, 2014
• Start date: October 2001
• Est. completion date: October 2010

Study information

• Verified date: June 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• porfimer sodium
IV
• Photdynamic Therapy (PDT)

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rigual NR, Thankappan K, Cooper M, Sullivan MA, Dougherty T, Popat SR, Loree TR, Biel MA, Henderson B. Photodynamic therapy for head and neck dysplasia and cancer. Arch Otolaryngol Head Neck Surg. 2009 Aug;135(8):784-8. doi: 10.1001/archoto.2009.98. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	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 years	No
Primary	Local Toxicity	Number of patients with an adverse event	30 days	Yes