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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Nestor R. Rigual, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000595166

NCT ID:

NCT00675233

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263