Principal investigator: Gordon H. Downie, MD, PhD
Co-investigators: Rosa E. Cuenca MD, Ron A. Allison MD, Brian Brodish MD, Claudio Sibata PhD and Anastasia Sigounas BS.

This study is designed to assess the ability of light (photodynamic therapy) to treat various types of cancer. The goal of this photodynamic therapy is to localize the "treatment effect" to just the tumor which may minimize the side effects of the treatment.

The drug which will be used is called Photofrin and it has been approved for the treatment of various kinds of cancer by the U.S. Food and Drug Administration. Photofrin administered by itself has little or no activity; however, once the drug is exposed to light, it becomes activated, which may, in turn cause the destruction of tumor tissue.

Plan and procedures
The investigators anticipate enrolling about 10-15 patients in this research study per year. The research team conducting this study at the Leo W. Jenkins Cancer Center consists of Dr. Gordon Downie (medicine doctor), Dr. Rosa Cuenca (surgical oncologist), Dr. Ron Allison (radiation oncologist), Dr. Brian Brodish (ear, nose and throat surgeon), Claudio Sibata PhD and Anastasia Sigounas (research coordinator).
Research subjects will receive a Photofrin injection two to three days prior to light treatment. This should take about 10-20 minutes, after which subjects can return home. However, their skin will be very sensitive to sunlight for up to 90 days following this infusion. Sunlight sensitivity could cause serious skin burns, even death, if direct exposure to sunlight is not avoided.

Once participants receive the injection of Photofrin, their skin and eyes will become photosensitive (sensitive to light). Photosensitivity reactions may occur in minutes, so immediately after receiving the Photofrin injection and for the first 30 days afterward, there are certain precautions participants must take in order to avoid a serious bun (sunburn, redness and swelling). These precautions include avoiding bright lights and direct sunlight. However, if the skin is exposed to direct sunlight, they will get severe sunburn, possibly requiring hospitalization.

After the first 15-21 days, participants must do a self-test for photosensitivity by exposing a small area of skin, on the back of the hand, to sunlight. One way to do this is to cut a small hole (about two inches) in a paper bag that they can put their hand into. They can expose the unprotected skin to sunlight for 10 minutes. If redness, swelling or blistering occurs within 24 hours of the exposure, study subjects will need to continue taking the precautions for another two weeks. If no reaction occurs within 24 hours of exposure, they may gradually increase their outings into sunlight.

Anyone with questions about the self-test or confusion should not perform the test and should call the study doctor or nurse to perform the test.

Study subjects will receive Photofrin 2-3 days prior to light treatment. Treatment will take place in Pitt County Memorial Hospital. Cleaning of the wound will be done 1-3 days after PDT. After hospital discharge participants will be followed on an outpatient basis after 7 and 30 days without biopsies, and 90 and 180 days after treatment with biopsies.

Potential risks and discomforts
Risks include swelling, potentially resulting in compromise of airway, which may necessitate tracheostomy placement, difficulty swallowing, stricture or stenosis formation, and perforation.

Although every effort will be made to ensure that during injection Photofrin will not spill over from the vein to the surrounding tissue, there is a possibility of such incidence. The injection site must be protected from light for as long as needed. To avoid any sunburn-like symptoms.

The study doctor will determine the appropriate length of time for skin protection. Because Photofrin is light-sensitive, it may cause burns to the skin at the injection site or eyes. Appropriate precautions of protection from room light and sunlight will begin immediately after drug administration and continue for at least 12 weeks, unless participants are otherwise instructed by the study doctor.

Participants will be asked to wear protective clothing on the entire body. Commercial sunscreens are not effective at protecting study subjects from the external light when Photofrin is in their blood. They will be instructed on how to protect themselves from external light exposure during the entire study period.

Due to the nature of its sensitivity to light, once injected with Photofrin, they should not undergo any surgical operation that may use strong lights during the treatment. In the event of emergency surgical procedures adequate measures should be undertaken to minimize exposure of the skin and other exposed tissues to operating room lighting.

Participants should protect their skin from direct sunlight or very bright indoor lighting (e.g. fluorescent lighting or tungsten discharge lamps) after Photofrin administration. Exposure to sunlight should be increased gradually and cautiously according to the study doctor's instructions. When outside, wear hats, long sleeve shirts, long pants or long skirt, gloves and sunglasses. They should avoid any dental or eye examinations for one month after the procedure to protect themselves from the strong light used during these kinds of examinations.

The most common side effects after taking Photofrin reported in other studies include itching, pain and burning, facial edema/swelling, hot flashes, redness of the skin, blistering, diarrhea, difficulty swallowing, nausea/vomiting, constipation, heartburn, coughing, phlegm, shortness of breath, sore throat, nasal obstruction, fever, feeling "out of sorts," pain, headache, toothache, earache, hoarse voice, insomnia, chest discomfort, stiffness.

The changes in hematology laboratory assessment attributed to Photofrin reported in other studies include increased and decreased white blood cell counts, decreased red blood cells and hemoglobin, and increased or decreased platelet counts in the blood that helps with clotting. The following changes were noted in urine: changes in color (green), urinary sugar, increased urinary protein and blood in the urine.

There may be risks to an embryo, fetus or nursing infant, and effects on semen are currently unknown. If someone becomes pregnant during their participation in the trial, she should contact her study doctor immediately.

There may or may not be any medical benefit to participants from participating in this research study. Information gained from this study may help other people who have cancer.