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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):

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
Head and Neck Cancer Drug: porfimer sodium Drug: Photdynamic Therapy (PDT)

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  (Clinical Trial)
Actual Enrollment : 30 participants
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 : October 2001
Primary Completion Date : August 2010
Study Completion Date : October 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 [ Time Frame: 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 [ Time Frame: 30 days ]
    Number of patients with an adverse event


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530088


Locations
United States, New York
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
More Information

Publications:
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 Posted: September 17, 2007    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014
Last Verified: June 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
Neoplasms by Site
Neoplasms
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents