Clinical trial · Interventional
Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer
Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and Stage I Carcinoma of the Oral Cavity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): safety issues
Summary
Brief summary (as posted)
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage I oral cavity cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | 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 treatment to the tumor bed on day 2. Treatment may repeat every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: HPPH
Primary outcomes (2)
- measure
- Evidence of dose limiting Toxicities (DLT)
- timeFrame
- First four weeks
- description
- Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.
- measure
- Tumor response
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Biopsy-confirmed diagnosis of 1 of the following:
* Mild to severe dysplasia
* Carcinoma in situ (CIS) of the oral cavity
* Carcinoma must be less than 3mm thick
* Stage I (T1) squamous cell carcinoma of the oral cavity
* Recurrent or primary disease
* No T2 or greater squamous cell carcinoma, exophytic CIS, or dysplasia lesions
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Total bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times the upper limit of normal (ULN)
* SGOT ≤ 3 times ULN
* Not pregnant
* Fertile patients must use effective contraception
* No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
* Prior therapy of any type allowed
* More than 4 weeks since prior and no concurrent chemotherapy or radiotherapyReferences
Publications (0)
Data not yet available