Clinical trial NCT00675233: Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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
  * 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

Primary outcomes:
measure: Toxicity
timeFrame: 6 weeks
measure: Tumor response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Hassan Arshad, MD
role: PRINCIPAL_INVESTIGATOR
References: