Trials / Completed
CompletedNCT00470496
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers. SECONDARY OBJECTIVES: I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients. II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens. III. Observe for wound complications. OUTLINE: This is a dose-escalation study of laser light. Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2. After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.
Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Hypopharynx
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Thyroid Cancer
- Recurrent Verrucous Carcinoma of the Larynx
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Stage I Adenoid Cystic Carcinoma of the Oral Cavity
- Stage I Basal Cell Carcinoma of the Lip
- Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage I Follicular Thyroid Cancer
- Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage I Lymphoepithelioma of the Nasopharynx
- Stage I Lymphoepithelioma of the Oropharynx
- Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage I Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Papillary Thyroid Cancer
- Stage I Salivary Gland Cancer
- Stage I Squamous Cell Carcinoma of the Hypopharynx
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Squamous Cell Carcinoma of the Oropharynx
- Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Adenoid Cystic Carcinoma of the Oral Cavity
- Stage II Basal Cell Carcinoma of the Lip
- Stage II Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage II Follicular Thyroid Cancer
- Stage II Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage II Lymphoepithelioma of the Nasopharynx
- Stage II Lymphoepithelioma of the Oropharynx
- Stage II Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage II Mucoepidermoid Carcinoma of the Oral Cavity
- Stage II Papillary Thyroid Cancer
- Stage II Salivary Gland Cancer
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HPPH | Given IV |
| DRUG | photodynamic therapy | Undergo laser light exposure |
| PROCEDURE | conventional surgery | Undergo surgery |
Timeline
- Start date
- 2006-10-19
- Primary completion
- 2011-10-28
- Completion
- 2018-08-30
- First posted
- 2007-05-07
- Last updated
- 2022-07-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00470496. Inclusion in this directory is not an endorsement.