Change in CIK Trial

Yesterday, while trying to schedule the CIK trial and follow-up labs, I discovered that the follow-up really can't happen at City of Hope as we had planned. The main issue is that Adrienne needs to have toxicity/safety checks at Stanford every three to seven days for the first 30 days following the infusion. Since this is a Phase I clinical trial, these checks are required by law and with the license through the National Cancer Institute. NCI is funding the study and they have very strict rules for how Phase I trials are conducted. This makes a lot of sense in terms of protecting patients but certainly messes up our plans. Adrienne will also need frequent labs, which we had hoped to do at City of Hope, but some of these can only be done at Stanford.

I have a call into the orthopedist to find out the risk of delaying Adrienne's hip surgery. Last summer, her AVN was between stages 1 and 2 (of 4 stages). AVN is a degenerative disease but the rate of progression varies in each person, typically between one and three years. The core decompression surgery she is supposed to have in December is only effective in stages 1 and 2. If you don't stop it then, you have to wait until stage 4, which means a total hip replacement. We really want to avoid that because it is a major surgery with lots of rehab and hips only last 15 to 20 years. Plus, it has been a major project to coordinate the docs at the children's hospital and those at the main hospital at Stanford.

So, stay tuned. Right now, we're thinking of moving the CIK trial up to December and delaying the hip surgery until March or May. It means Daniel would under apherisis right around Thanksgiving and Adrienne would get the infusion as soon as she finishes her final exams. That would give us the 30 day window needed for her follow-up. We hope that the final labs on day 56 can be collected at City of Hope and sent back to Stanford.