Trials / Withdrawn
WithdrawnNCT02119728
Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity
A Randomized Multicenter Phase II Study Using HPPH With PDT Versus Standard of Care Surgery for Patients With T1/T2 Squamous Cell Carcinoma of the Oral Cavity
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HPPH | Undergo photodynamic therapy with HPPH |
| DEVICE | Light Infusion Therapy™ | Undergo photodynamic therapy with HPPH |
| PROCEDURE | therapeutic conventional surgery | Undergo standard of care surgery |
Timeline
- Primary completion
- 2017-01-01
- First posted
- 2014-04-22
- Last updated
- 2016-04-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02119728. Inclusion in this directory is not an endorsement.