Status:
COMPLETED
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Basal Cell Carcinoma of the Lip
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00470496
Start Date
October 19 2006
End Date
August 30 2018
Last Update
July 25 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263