Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent … (NCT00470496) | Clinical Trial Compass
CompletedPhase 1
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
United States15 participantsStarted 2006-10-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Patie…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity