Overview

Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

Status:
Withdrawn
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborators:
Biolitec Pharma Ltd.
National Institutes of Health (NIH)
Treatments:
Temoporfin
Criteria
Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the
oropharynx or oral cavity that are amenable to surgery

- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy
(PDT) (accessibility as determined by the physician)

- Life expectancy of at least 6 months in the judgment of the physician

- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)

- White blood count > 3,000 per microliter or

- Absolute neutrophil count (ANC) > 1500 per microliter

- Serum calcium within normal limits; note: serum calcium will be corrected for low
albumin, if necessary

- Subjects of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately

- Subject or legal representative must understand the investigational nature of this
study and sign an Institutional Review Board approved written informed consent form
prior to receiving any study related procedure

Exclusion Criteria:

- Subjects who have had radiotherapy within the last 3 months

- Subjects with known brain metastases should be excluded from this clinical trial

- Tumor invading a major blood vessel (such as the carotid artery)

- Tumor invading the skull base

- Subjects with ophthalmic disease

- Tumor is not clearly shown on an imaging scan/location and extension of tumor that
precludes effective PDT, in the judgment of the primary investigator (PI)

- Location and extension of the tumor precludes an effective interstitial photodynamic
therapy (iPDT)

- Patients with known hypersensitivity to porphyrins or with porphyria

- Has distant metastasis that decreases life expectancy to less than 6 months

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or nursing female subjects

- Unwilling or unable to follow protocol requirements and the light exposure precautions

- Any condition which in the investigator's opinion deems the subject an unsuitable
candidate to receive study drug