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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01941 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 74606 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (intraoperative PDT) | Experimental | Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPPH | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor progression or recurrence | From baseline until objective tumor progression, assessed up to 5 years | |
| Uptake and distribution of HPPH in resected tumor tissue | Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Arshad | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23868427 | Derived | Rigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387. |
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| photodynamic therapy | Drug | Undergo laser light exposure |
|
|
| conventional surgery | Procedure | Undergo surgery |
|
|
| ID | Term |
|---|---|
| D018304 | Esthesioneuroblastoma, Olfactory |
| D012468 | Salivary Gland Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D013964 | Thyroid Neoplasms |
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020431 | Olfactory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000230 | Adenocarcinoma |
| D000231 | Adenocarcinoma, Papillary |
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| ID | Term |
|---|---|
| C083998 | 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a |
| D010778 | Photochemotherapy |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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