Clinical Trial Options

Dr. Atkins gave Aimee 2 options at this point, both clinical trials. And we need to decide between the 2 within the next 2 weeks.

Option 1:
- a phase III trial (meaning that the medication is safe, and they are trying to determine its precise effectiveness.)
- It combines a RAF pathway inhibitor (Sorafenib) with chemotherapy (carboplatin and paclitaxel, developed in the 80's). The RAF pathway inhibitor ideally should prevent cancerous cells from multiplying.
- side-effects are typical of chemotherapy-- hair loss, nausea, etc., i.e., all that nastiness.
- It's not entirely clear what the response rates are for advanced melanoma.

From the Consent Form:

[Sorafenib] may slow the growth of your cancer by stopping cancer cells from multiplying and growth of vessels that support cancer cells. Carboplatin and Paclitaxel in combination with [sorafenib] may have additional effect on your cancer that has spread or cannot be treated with surgery.

Option 2:

- a phase I/II trial (meaning they don't know how safe this drug is. The trial is in part to determine the proper, safe, and effective dosage. It's also investigational-- meaning they don't know what kind of effects to expect. They've only tested it in a laboratory.)
- It involves an oral dosage of RAF265 (another cancer growth inhibitor) given over various periods of time.
- Side effects are generally unknown ("This is the first study of RAF265 in humans"). But at the same time, they can extrapolate probable and possible side effects. It is predicted to be moderate compared to option 1.
- From the consent form:

Labratory studies have shown that RAF265 slows or inhibits the growth of melanoma cells and melanoma tumors.

Dr. Atkins recommends the 2nd option for a couple of reasons. First, he thinks it has more potential to be effective. Second, if Aimee takes the first option, she can't take the second (this is the way a lot of clinical trials work-- once you've had some treatment, it precludes you from others.). But if she takes the second option, she still has the possibility of the first.

Both trials will take place here in Boston. We asked him whether there are other options in DC or Houston, and he said that Houston is doing the same thing, and DC is focusing on a treatment that Aimee is ineligible for (wrong blood type).



So-- after all that ... We're leaning towards the second option, mostly because Atkins thinks it's more promising and it won't cut off other possibilities.