Clinical trial · Interventional
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
- 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)
This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) 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. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
Conditions
Conditions (55)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Basal Cell Carcinoma of the Lip | Lip Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED | — |
| Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED | — |
| Recurrent Lymphoepithelioma of the Nasopharynx | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Oropharynx | — | UNRESOLVED | — |
| Recurrent Metastatic Squamous Neck Cancer With Occult Primary | — | UNRESOLVED | — |
| Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| HPPH | Drug | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (intraoperative PDT)
- description
- Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.
- interventionNames
- Drug: HPPH
- Drug: photodynamic therapy
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
- timeFrame
- 30 days
Secondary outcomes (2)
- measure
- Time to tumor progression or recurrence
- timeFrame
- From baseline until objective tumor progression, assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator) * Female patients must not be pregnant (documented by human chorionic gonadotropin \[HCG\] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB) * No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT Exclusion Criteria: * Patients with unresectable tumors * Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds * White blood cell (WBC) \< 4,000 * Platelet count \< 100,000 * Prothrombin time 1.5 times above the upper normal limit * Total serum bilirubin \> 2.0 mg/d * Serum creatinine \> 2 mg% * Alkaline phosphatase (hepatic) \> 3 times the upper normal limit * Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit * Patients on concurrent chemotherapy or radiation therapy will be excluded * Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days * Has not recovered from toxicity of prior therapy
References
Publications (1)
- DERIVEDRigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387. PMID 23868427