I have spoken with my family and come to an initial consensus of terminating my participation in the SWOG clinical trial.
I have since read through the study documentation (www.ClinicalTrials.gov/S1602) as well as the consent forms and found that indeed, the dosing can be reduced down to 1/100 of the full dose.
I have been in contact with the research coordinator here in Boise and he has forwarded my emails on to Dr. Brassell and will be at my appointment next Wednesday September 30, 2020 in order to help express my concerns, needs, etc.
There are four reduction levels possible within the trial 1/3 (26.67 mg). 1/4 (20 mg), 1/10 (8 mg) and 1/100 (0.8 mg) - my hope is we can go all the way down for this final maintenance round and see about increases in 6 months at the next scheduled maintenance round.
Thank you all for your input as this is what helped me to do the digging and find out what options I have to stay in the study (it is covering the cost and availability of the Tokyo BCG) for the entire course so that I might have the greatest overall outcome possible.
As I am in a clinical trial, I don't know if the doc can play around with the dosage.
My intention is to stop the involvement with the clinical trial and transition to something we might have a bit more control over.
My biggest concern is the notion of BCG shortages and it not being readily available at the times I would continue to receive it. But I think we will have to cross that bridge when it occurs.
I am hopeful doc will agree to something like 6 mos scopes followed by 1 round of maintenance as I tolerate that first instillation just fine (or as all have mentioned, perhaps a much lower dosage - although my medical/scientific knowledge makes me think the immune response I have to the 2nd & 3rd rounds will be the same regardless of the dosage).
As of today (4 weeks post round 2 instillation) I am still having bladder spasms, although greatly reduced in severity, peeing every hour maximum - sometimes sooner depending on my liquid intake, and sleeping about 2-3 hours at a pop.
I see the doc in one week and will post some info regarding the decision.
Glad to know someone is on the clinical trial. Did they use 50 mg per instillation for the 6 weeks induction course?
Dr. Shashi Kamat, a well know figure in the bladder cancer community, who is the professor and clinical urologist at MD Anderson in Texas , Kamat says that the duration of treatment with BCG seems to matter more than the dose of the therapy. The patients who received 3 years of the full dose had a 5-year disease-free rate of 64.2% vs 58.8% with 1 year of maintenance therapy. When a 1/3 of dose is used, the number changes to
62.6% vs 54.5%. So, it makes 6-8% difference in recurrence rate between 3 year vs 1 year. I have listed the link below.
So, you may want to ask your urologist to see reducing the dose will mitigate the side effects you are having. The dose reduction can be 1/3 or even to 1/10 and continue with 3 year protocol rather than stopping after one year. I recall 1/10 dose maintenance works as well as pointed out by Dr. Lamm.
I understand there are already over 750 patients on the trial, but still needs more people to get to 1000 patients. I think medical communities know that Tokyo-172 strain or any other BCG strain available in the world should give comparable efficacy with comparable side effects as they all come from one original strain which was developed at the Paseur Institute but WHO says each stain possesses different characteristics.
Merck website says each vial come with 50mg wet weight. Tokyo-172 strain which is manufacture by Japan BCG corporation comes in 40mg and 80mg. The company website says usually 80mg is instilled and administered 8 weeks.
There are many protocols out there. My URO, who studied under Dr. Lamm in San Antonio 40+ years ago, had me on a total of 6 weeks on, 6 off then another 6. I have seen 6 plus 3 weeks every 3 months for 2 years then every then 3 weeks on 6 months out until 2 more years have passed. I have seen once a month for 12 weeks. I am not sure anyone has an optimal strategy other than to say you have attacked it.
The points is you have done the initial induction stage+ so, as Sara Anne posted you havea good floor. Not worth ruining your bladder in the process. Let us know what your follow up might be as we all learn bits and pieces as we go.
DX 5/6/2008 TAG3 papillary tumor .5 CM in size. 2 TURBS followed by 6 instillations of BCG weekly with a second round of 6 after a 6 week wait.