Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity

Withdrawn before enrolling · Phase 2

Conditions studied: Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Verrucous Carcinoma of the Oral Cavity

In brief

This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.

Key facts

Study ID: NCT02119728
Run by: Roswell Park Cancer Institute
People needed: 0
Last updated by the study team: 2016-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
Histologically confirmed squamous cell carcinoma of the target tumor(s)
Tumor thickness is 4 mm or less (in the judgment of the physician)
Computed tomography (CT) of the neck to confirm staging
Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
Life expectancy of at least 12 months in the judgment of the physician
Patients 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
Patient 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

You may not qualify if…

Patients who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients with known brain metastases should be excluded from this clinical trial
Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
White blood cells (WBC) < 4,000
Total serum bilirubin > 2 mg/dL
Serum creatinine > 2 mg/dL
Alkaline phosphatase (hepatic) > 3 times the upper normal limit
Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
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
Nodal disease as detected by clinical exam or CT
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
Received an investigational agent within 30 days prior to enrollment

Where it is running

Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.