Now that week 1 of Dave’s clinical trial is ending, I will try to answer some questions we have been asked by others. First, this is a stage 2 trial. In a stage 1 trial, the safety of a treatment is tested, then in stage 2 a low number of people are tested, often at different dosage, to determine the effectiveness of the treatment. In this case, the plan is to get 90 people at the 6 sites around the country. Once again we are in the right place. Not only are we at one of the sites, but it is only 15 minutes away. Two thirds of the people will be doing what Dave is doing and one third will receive only low dose chemo and the vaccine. Dave’s group gets the low dose chemo and vaccine for two sessions, and then the last form sessions involve the infusion of an altered form of the listeria bacteria. Both treatments are designed to kick start the immune system. The trial is planned to last 20 weeks.
It is clearly stated that a person may drop out at any time for any reason. If the scans or blood work show the disease is spreading the doctor might suggest the use of a more conventional treatment. If this level of the trial is helpful, a stage 3 trial will be on a larger group of people to gather data prior to seeking FDA approval. For us week one started last Thursday. Because Tuesday fits better in our lives he will move up a day at a time to make this change. His next treatment will be at the start of week 4. The first day June 13, will be the low dose chemo with the vaccine the next day.
He is having some side effects. The 6 doses of the vaccine are given just under the skin, 2 in the left upper arm, and 2 each on the top of each thigh. After the injections were given each site was slightly red and swollen. Saturday morning the places on his left arm were bright red and about 3 inches in diameter. His legs didn't react as much but overall he felt like he was getting the flu, very tired and achy. Now the question continues about why the legs have not reacted as fast as the arm. In addition, why is his lower abdomen swollen and hurting? There are more questions than answers.
Another question we have been asked is about the blood draws. The 4 small tubes were the normal draw before the chemo to make sure everything is okay. According to the consent form the 16 large tubes will be taken again at week 4, 7, 10, 13, and 16. The consent form said this was about 10 tablespoons, about 2/3 cup. No wonder they are pushing him to drink lots of fluids. These are all for research so we don't know exactly what they are looking at. Before week 10 he will have the full set of CT scans and a EKG again. All the labs, scans and drugs are paid for by the trial so there is no hassle or pre-approval needed. I hope this answers some of the questions for you. Please don't hesitate to ask, someone else is probably wondering too.
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