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Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008

Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00675233
  Purpose

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.


Condition Intervention Phase
Head and Neck Cancer
Drug: HPPH
Procedure: laser therapy
Phase I

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-Devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Tumor response [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   April 2008
Estimated Primary Completion Date:   January 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.

Secondary

  • To determine response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of laser light therapy.

Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-confirmed diagnosis of 1 of the following:

    • Mild to severe dysplasia of the larynx

      • Dysplastic lesions ≤ 3 mm in thickness
    • Squamous cell carcinoma in situ of the larynx

      • No exophytic carcinoma in situ
    • T1 squamous cell carcinoma of the larynx

      • Tumor ≤ 3 mm in thickness
      • No T2-T4 squamous cell carcinoma of the larynx
  • Newly diagnosed or recurrent disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Total bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • SGOT ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
  • No porphyria
  • No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

  • Any prior therapy allowed
  • At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675233

Locations
United States, New York
Roswell Park Cancer Institute     Recruiting
      Buffalo, New York, United States, 14263-0001
      Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Nestor R. Rigual, MD     Roswell Park Cancer Institute    
  More Information


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

Study ID Numbers:   CDR0000595166, RPCI-I-119207
First Received:   May 8, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00675233
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the larynx  
stage I squamous cell carcinoma of the larynx  
stage III squamous cell carcinoma of the larynx  
stage IV squamous cell carcinoma of the larynx  
stage 0 laryngeal cancer  

Study placed in the following topic categories:
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Laryngeal Neoplasms
Recurrence
Carcinoma
Epidermoid carcinoma
Respiratory Tract Diseases
Head and Neck Neoplasms
Carcinoma in Situ
Carcinoma, squamous cell
Laryngeal carcinoma
Laryngeal Diseases
Carcinoma, Squamous Cell

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2008




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