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 - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by (Responsible Party):	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00530088

Purpose

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	Intervention
Head and Neck Cancer	Drug: porfimer sodium

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Oral Cancer

Drug Information available for: Porfimer sodium Dihematoporphyrin ether Trioxsalen

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Local toxicity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	29
Study Start Date:	February 2003
Study Completion Date:	October 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

IV

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00530088 History of Changes
Other Study ID Numbers:	CDR0000564841, RPCI-RPC-01-08
Study First Received:	September 13, 2007
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

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:

Carcinoma
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

Trioxsalen
Dihematoporphyrin Ether
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 07, 2012