Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | UNRESOLVED |
| laser therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment PDT
- description
- Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment.
- interventionNames
- Drug: HPPH
- Procedure: laser therapy
Primary outcomes (2)
- measure
- Toxicity
- timeFrame
- 6 weeks
- measure
- Tumor response
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 radiotherapyReferences
Publications (0)
Data not yet available