Clinical trial · Interventional
Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and 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): implementation issues
Summary
Brief summary (as posted)
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, 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. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions
Conditions (10)
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 Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage II Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
| temoporfin | Drug | Temoporfin | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (interstitial photodynamic therapy using temoporfin)
- description
- Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
- interventionNames
- Drug: photodynamic therapy
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- Drug: temoporfin
Primary outcomes (1)
- measure
- Frequency of adverse events, graded according to NCI CTCAE version 4.0
- timeFrame
- Up to 30 days after surgical resection
- description
- The frequency of toxicities will be tabulated by grade.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery * Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician) * Life expectancy of at least 6 months in the judgment of the physician * Blood urea nitrogen (BUN) =\< upper limit of normal (ULN) * White blood count \> 3,000 per microliter or * Absolute neutrophil count (ANC) \> 1500 per microliter * Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary * Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Subjects who have had radiotherapy within the last 3 months * Subjects with known brain metastases should be excluded from this clinical trial * Tumor invading a major blood vessel (such as the carotid artery) * Tumor invading the skull base * Subjects with ophthalmic disease * Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI) * Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT) * Patients with known hypersensitivity to porphyrins or with porphyria * Has distant metastasis that decreases life expectancy to less than 6 months * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female subjects * Unwilling or unable to follow protocol requirements and the light exposure precautions * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
References
Publications (0)
Data not yet available