A Phase 2 interventional study of HPPH and Light Infusion Therapy™ in Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx and Recurrent Verrucous Carcinoma of the Oral Cavity, sponsored by Roswell Park Cancer Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.
SECONDARY OBJECTIVES:
I. To determine improvement in quality of life (QoL) using the University of Washington Quality of life questionnaire version 4.
II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
III. To explore progression-free survival in this patient population treated with HPPH mediated PDT.
TERTIARY OBJECTIVES:
I. Immune markers (T cells). II. To investigate the correlation of the tri-modal optical spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatments arms.
ARM I: Patients undergo standard of care surgery on day 1.
ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
After completion of study treatment, patients are followed up 3-4 months for 1 year, 3-6 months for 1 year, 4-8 months for 1 year, and once a year for 2 years.
1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →Roswell Park Cancer Institute is the lead sponsor of 417 studies on the registry; 64 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergo standard of care surgery on day 1.
Procedure: therapeutic conventional surgery
Patients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
Drug: HPPH · Device: Light Infusion Therapy™
Undergo photodynamic therapy with HPPH
Also known as: Photochlor
Undergo photodynamic therapy with HPPH
Also known as: PDT, therapy, photodynamic
Undergo standard of care surgery
Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
Objective tumor response will be tabulated overall. Tumor response will be determined by comparing photographs of the treated site (with reference ruler) before and after PDT. Efficacy (e.g., tumor response) will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
Time frame: 3 months after treatment
Changes in quality of life evaluated by the University of Washington Quality of Life Questionnaire version 4
In the analysis of QoL simple data analyses will initially take place including individual patient level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. All tests will be two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions.
Time frame: Baseline to up to 5 years
Frequency of toxicity graded according to NCI CTCAE version 4.0
The frequency of toxicities will be tabulated by grade across all cycles. The safety of the interventions will be assessed through the evaluation of grade 3 or higher toxicities deemed possibly related to treatment. Toxicity rates will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
Time frame: Up to 6 weeks after treatment
This study is withdrawn, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a
Squamous Cell Carcinoma of Head and Neck →
Roswell Park Cancer Institute →