Cycle 1 - Days 1 & 2

Our first appointment on Thursday was an audiology exam at 9:30 am. It was a fairly typical hearing test used as a baseline. The chemo treatment was scheduled to begin at 3:00 pm and we finally found out Kevin was accepted into the study group after checking in for that appointment. First more baseline tests – physical exam, EKG, blood draw and a cognitive/neurological exam. They put in two IVs – one for blood draws and one for the chemo. With the chemo IV they gave Kev some Zofran (anti-nausea med) and then finally started the ANG1005 at about 4:30. The plan was to administer the 500 ml mixture over 1 hr period. Because this drug has never before been tested in humans they keep very close watch on the study group participants. Eight blood draws altogether will be taken before we leave on Th –at the start of the infusion then every 30 minutes for the first 1 ½ hrs and then once every hour for the next 4 hours. The blood draws are for pharmacokinetic (PK) testing which measures the amount of the drug in his body at different time points. Vitals are taken every 15 minutes during the infusion, 30 minutes after the finish and then once every hour for the next 4 hours. A total of 3 EKGs will be run throughout the event.

After about 15-20 minutes one of the Researchers comes in and asks if we had started and I tell him “yes, it’s that milky colored one.” He seemed a bit confused and mumbled back, “milky?...yes…milky…I’ll be right back”. Next comes up the pharmacy Drs who introduce themselves, exam the drug, sort of whisper amongst themselves – “it was clear when we mixed it…must have turned cloudy after we shipped it up here…we’ll be right back.” They all return with the floor nurse and explain that they spoke with the pharmaceutical company, Angiochem, and were told the drug should be fine and Kev should be fine, but asked for it in writing and were going to stop the IV until the fax arrived. Apparently Angiochem changed their minds, because after about half an hour we were told they were not going to restart the infusion. Kev had received about 2/3 of the expected dose and again we were assured he should be fine, but an investigation would be conducted. We stayed the required 4 hours and completed the remaining the blood, EKG & vitals. The drug made Kevin very sleepy and he pretty much dosed off as soon as they started it, but other than that there didn’t seem to be any other side effects. Kev did the give the Researcher a bit of a scare when in mid-sentence he nodded off – one of his classics – head tilts back, eyes lids at half mast, eyes roll back in their sockets and mouth drops open. After seeing his concern, I explained he was just sleeping :-0

On Friday we went back for more blood and a physical exam. They informed us the preliminary investigation determined that the cloudy effects of the drug are a result of the concentration. They have just recently started this highest level of concentration and have decided from now on they will increase the dilution to 1 liter and change infusion to 2 hours. Kev was the second participant to receive the highest concentration and although the cloudy effects were not recognized on the first participate, they believe it was present. We were again assured Kev “should be fine” :-)

We are still chasing a very resilient urinary tract infection (UTI) and were given yet another antibiotic to try. Apparently the bacteria remaining were resistant to the previous two antibiotics he was taking. The Researchers are very careful about infections and told us any fever above 100F means a trip to the ER. Next appointment is Wed for more routine tests.