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
2 other identifiers
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2006
CompletedFirst Submitted
Initial submission to the registry
May 3, 2007
CompletedFirst Posted
Study publicly available on registry
May 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedJuly 25, 2022
July 1, 2022
5 years
May 3, 2007
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
30 days
Secondary Outcomes (2)
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
Study Arms (1)
Treatment (intraoperative PDT)
EXPERIMENTALPatients 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.
Interventions
Undergo laser light exposure
Undergo surgery
Eligibility Criteria
You may qualify if:
- Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
- Female patients must not be pregnant (documented by human chorionic gonadotropin \[HCG\] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
- No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT
You may not qualify if:
- Patients with unresectable tumors
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- White blood cell (WBC) \< 4,000
- Platelet count \< 100,000
- Prothrombin time 1.5 times above the upper normal limit
- Total serum bilirubin \> 2.0 mg/d
- Serum creatinine \> 2 mg%
- Alkaline phosphatase (hepatic) \> 3 times the upper normal limit
- Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit
- Patients on concurrent chemotherapy or radiation therapy will be excluded
- Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
- Has not recovered from toxicity of prior therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Related Publications (1)
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.
PMID: 23868427DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hassan Arshad
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2007
First Posted
May 7, 2007
Study Start
October 19, 2006
Primary Completion
October 28, 2011
Study Completion
August 30, 2018
Last Updated
July 25, 2022
Record last verified: 2022-07