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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00675233

Enrollment

Registered

2008-05-09

Start date

2008-04-25

Completion date

2018-09-27

Last updated

2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGHPPH

Given IV

PROCEDURElaser therapy

Escalating light doses with 665 nm light

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Toxicity	6 weeks
Tumor response	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026