My sister-in-law has been asked to particapte in a Phase II trial of a gene therapy product called INGN 201 for people with "advanced resectable squamous cell carcinoma...)

My wife (in Kansas City with her sister)faxed me the information on the trial and I was wondering if anyone might have experiences with this product in particular, but also have some questions about clinical trials in general.

This products introduces a p53 gene during surgery and 2-3 days after surgery. Radiation and chemo will follow on a prescribed schedule. They are trying to determine if INGN 201 may reduce the percentage of recurrance of cancer.

There are likely side effects, the most concerning (to me) are infections at the injection site and drain tube.

Not being versed in the protocals of clinical trials, I was surprised that the expense for additional tests and examinations required by the trial are borne by the patient/insurance company and if the drug goes to market during the trial (unlikely) it would have to be purchased by the patient. Of course, her insurance company would have to approve.

Does this sound like standard procedure for a trial? I'm kind of surprised that they shift the additional financial burden to the patient.

I think her inclination might be to participate to try to make something positive come out of the experience, but I'm kind of wondering about adding to the financial load (they'll want to moniter her for five years) and the potential of additional side effects to the known ones from the surgery, radiation and chemo.

Any thoughts?

bob