Clinical trial or not... that is the question up next.

The protocol for Tim’s chemo lasts until June, 2007. The standard protocol has 16 rounds of the triple whammy with other weeks just having vincristine. Around week 13, radiation will also start and last for five weeks. He’ll have to go to the radiation oncology lab each weekday during those five weeks.

Tim was offered entry into a phase three clinical trial for low risk patients. He is actually on the high end of the low risk category. This trial would modify the protocol to eliminate the last 12 triple whammies and replace them with just the administration of dactinomycin. There are also some breaks in administering the dactinomycin. Both protocols have some breaks on the vincristine.

A phase three clinical trial means that they have already decided that the new protocol is likely to become the recommended one for the future. This trial is to build up patient data to compare survival rates with or without the full 16 rounds. Since the cancer Tim has is rare enough, they are only looking for 650 patients in this trial. A normal phase 3 trial would have several thousand patients. However, rhabdomyosarcoma survival rates have been going up over the last 20 years due in large part to the aggressive treatment protocol. Backing down on that protocol is risky business.

Tim has been weighing the risks of staying in the clinical trial or going with the initially recommended protocol. The third of the chemo drugs, cyclophosphamide if given over the full course of treatment will continue to weaken Tim, has the high potential for causing sterility, and has the late term (after treatment is finished) potential for causing leukemia. Seems strange but also makes sense that these chemo drugs could themselves cause a cancer. Of course, the risk of a recurrence of the original rhabdomyosarcoma is the risk that gets reduced by getting the full 16 cycles of triple whammies which include the cyclophosphamide.

Tim had to decide right at the beginning to enter the trial because he could always leave the trial but could not enter after treatment had started. So we did sign up to enter the trial. The experiment to run would be to see how the triple whammies would affect Tim. Would they pound his blood counts to the ground, make him super tired or keep him out of school? It seems now, that we have gotten better at preparing for the triple whammies and for the follow up care at home over the next few days. So, Tim is really leaning towards exiting the trial and going back to the recommended protocol of all 16 rounds of cyclophosphamide. We have one more round to go before that decision needs to be made final.

It is incredibly difficult of course to make such a decision. If the triple whammies were causing long hospital stays and/or extended recovery times, it would be easier to decide to stay in the trial. Tim is improving each time he goes through the major cycles. So that makes me think he will decide to leave the trial and take on the full set of major cycles.

I hope that his body continues to adjust for the better with the continued administration of the chemo drugs. It seems to be going that way. I think exiting the trial will be the choice Tim makes and of course that is a decision that we will fully support.

--bob