Some Relevant Background
We first learned about the University of Connecticut (UCONN) HSP70 vaccine trial in October, 2002 when I joined the online CML group.  We were immediately intrigued by what seemed to be some impressive responses:  Out of the five trial participants at the time, two of the List members had achieved molecular remission during the vaccine trial.  We began to gather as much information as we could about the trial such as inclusion/exclusion criteria, study procedures, background studies, etc.  We consulted with our more expert List members and, of course, with Dr. Druker and our local oncologist, Dr. Bashey.  I also emailed the trial participants directly and asked them to share their experience and thoughts with us.  We came to the conclusion that, for Rob, the risk seemed low; the potential benefits could be great. 

Perhaps we were more receptive to the idea of a Phase I vaccine trial because of Rob's rocky start with Gleevec.  He was diagnosed in May, 2002 with CML in the Chronic phase.  But he had some Accelerated features including an extremely high WBC and platelet count, high basophils and a very enlarged spleen.  Most worrisome was the fact that Rob did not achieve hematological remission on 400 mg by August, 2002.  Dr. Druker and Dr. Bashey both suggested the dose be raised to the full 800 mg.  We were relieved to find Rob achieved hematological remission almost immediately on this higher dose and, in fact, demonstrated a pretty good FISH result, down from 100% to 52% according to the  FISH performed in September, 2002.  Nevertheless, we knew Rob might need all the help he could get in lowering those Phillies and keeping them down.

I emailed Elizabeth Laska, the clinical research nurse in charge of the HSP70 trial at UCONN.  I sent her a summary of Rob's history and expressed our interest in participating in the trial.  I followed up with a phone call, which she returned promptly.  She agreed that Rob appeared to be an ideal candidate for the trial and asked me to FAX his initial BMB and HLA typing results, Dr. Druker's consult notes, recent labs, recent FISH results, and our physician's Progress Notes.  I, in turn, asked her to send me a copy of the Informed Consent form that outlines study procedures and the risks and benefits of participating in the trial.  Elizabeth emphasized that time was of the essence; there were only two spots left and several people were clamoring to enter the trial.   Fortunately, we kept ongoing records which included most of what Elizabeth needed.  I went down to our University's Medical Records department, collected the remaining documents and sent everything to Elizabeth the very next morning.  We wanted to have the option of participating, even if Rob decided ultimately to decline the opportunity.  But the choice seemed clear to us.  We decided to enroll and a date for study entry was set for November 20, 2002, just two weeks away.

The logistics were not easy for us.  First, the trial required a bone marrow biopsy within 3 months of study entry.  Rob had a FISH done in September, but that would not suffice; so we scrambled to get a BMB/BMA performed at the busy UCSD clinic in time for his November 20 entry date.  In addition, Rob's participation would require a great deal of time on his part.  The Phase I trial involved an initial, 3-day work-up, including a physical exam and a process called leukapheresis during which white blood cells would be filtered from the blood.  From these white blood cells, the tumor cells would be obtained and used to prepare the HSP70 vaccine - a process taking about 6 weeks.  Once the vaccine was ready, Rob would receive one vaccine per week for 8 weeks.  Mid-trial, just before the fifth vaccine, Rob would have another BMB cytogenetics analysis, FISH and PCR done.  Two weeks after the last vaccine (at week 10), these tests would again be repeated. 

We live in California, 3,000 miles away from UCONN.  The Phase I trial paid for lodging and taxi to and from the airport.  We were responsible for airfare.  In addition, we have two young children, aged 2 and 4, who are very attached to their Daddy.  Finally, Rob has continued to work full time as an engineer at Scripps Institution of Oceanography.   Fortunately, Rob's boss has been extremely supportive of Rob during this entire illness and we had a great deal of flexibility in this area.   We entertained the thought of Rob taking a Leave of Absence from work and staying those 10 weeks in Connecticut, but that would seriously affect his work projects and Rob didn't like the idea of being gone from home for such a long stretch.  We considered flying back and forth every week, but there were the issues of airfare expense and exposure to those nasty airport germs.  We finally decided he would stay for two vaccines at a time, flying home for a few days in between.  We made airline reservations for his initial visit on November 20, and for his first two vaccines.