Dr. Green, my Atlanta urologist heard a presentation By Dr. O'Donnell and thought O'Donnell’s protocol was the best for my case. My history:

Sept 97: increase in urinary urgency, small piece of tissue, 1 drop, lightly tinted urine. PSA 0.6

Oct 98: Passed tissue and blood. Hurt to urinate. Urgency intense. Prostate OK. Tissue to path.

Oct 12, 98: IVP; OK, 1 uterer a little dilated. Cystoscope: no apparent tumors but 'mushy' spot.

Oct 30, 98: Cyctoscopy, bilateral Retrograde Pyelogram, and bladder biopsy. Results: Stage 0/Tis/Carcinoma in situ. Grade? No invasion. Mawd GP confirms NS hosp. path

Nov 12, 98: 1st of 8 BCG instillations.

Feb 2, 99: Cytology. Results not good. Saw abnormal cells.

Feb 15, 99: 2nd biopsy, bilateral Retrograde Pyelogram at Northside.
Results: Visual Saw a couple of irritated spots. 2nd biopsy path results; flat tumor with papillary component: transitional cell carcinoma, Grade III of IV. No definite stromal invasion. Only a few smooth muscle fibers present in sample.

The 2nd biopsy shows that the first round of treatments didn't get rid of the cancer. I have Grade III of IV CIS (Stage 0,Tis) that didn't seem to be phased by 8 weekly treatments of BCG. Will start a new round of weekly treatments the week of March 8th. It will be the same type of treatment (applying the agent directly into the bladder) but the agent will be stronger (Interferon added to the BCG).

Treatment begins March 25th and consists of 6 weeks of instillations with [1/3 BCG + Intron A]. Very expensive--6 weeks cost $7200 - $10,000.
 
Dr. Michael O'Donnell, Harvard Med School, seems to be the leader in this protocol and has had success in treating cases like mine ( 80% Complete Responses (ie. success) but on small number of patients under study (ie. 6 out of 7 in one study and 4 out of 5 in another). My doctor consulted with Dr.O'Donnell over the phone and will give me O'Donnell's protocol in Atlanta. O'Donnel is coordinating a nationwide study on this protocol which will start pretty soon.

Finished 6th treatment April 28, 1999. Tolerated instillations well. They made me more tired than the BCG only treatments. I want to sleep more. I also had minor headaches that would come and go. A ringing in both ears that still exists when I block out all external noise started around the time I started taking Oncovite between the end of my BCG only course of treatments and the beginning of my BCG + Intron A treatments). Will do Cytology (urine analysis) for preliminary analysis on May 18, 1999 and 3rd biopsy three weeks later.

Other info:

Dr. Leonard Gomella, has participated in studies with Dr. O'Donnell, and is studying a protocol where patients who have failed two courses of six BCG treatments each are instilled with interferon A on Monday and with Full BCG the next Wednesday. They are treating patients whose urologists had recommended bladder removal. After six weeks course of interferon + BCG is completed, no more treatments are given. The patient is monitored for 2 years via cystos & biopsies. If the cancer recurs, the patient is dropped out of the program to return to some other form of treatment. They have had some success but I don't know to what level.

Four urologists I've talked to recommend ### LINK NOT FOUD ###Oncovite--I'm taking Dr. Lamm's dosage.

Dr. Keane of Emory says I should go with Dr. Gomella's protocol of [full BCG + 100 units of intronA] to have the best chance of beating my GradeIII CIS.

Update March 3, 2000
I just completed the last of seven treatments by Dr. Michael O'Donnell, in Boston. He used 1/10 the normal amount of BCG plus 100 million units of IntronA (interferon) in the solution which was instilled into both kidneys (catheter to stints in the ureters to kidneys).
 
Remember I had previously undergone 6 treatments of 1/3 BCG + IntronA (after 8 treatments of BCG had failed). My cytology came back improved but atypical cells present". So we did bladder biopsy it came back negative (yea!).
 
I then did 3 maintenance treatments: 1st 1/3 BCG + 100 MU IntronA; 2nd & 3rd: 1/10 BCG + 100 MU IntronA. The 'poke and peek' showed the bladder looking good, no tumors, just some red spots (often caused by the treatments). The cytology, using voided urine from the bladder, came back positive. So the bladder seemed to be cured but the urine still had cancer cells in it (bummer!)
 
A comprehensive set of tests were done to try to determine just where the cancer was coming from. Dr.O'Donnell has found that about 20% of the time the cancer cells can migrate from the bladder to the ureters or kidneys. He recommended and Dr. Green in Atlanta, did localized cytologies on each kidney, each ureter, the bladder (collecting the cytology sample after the bladder had been washed with a saline solution) and a bladder biopsy. The biopsy came back negative (yea!) but the cytologies all came back atypical, indicating that cancer was still somewhere in my system.
 
So I decided to go to Boston and have Dr.O'Donnell treat my entire urinary system with 1/10 BCG + 100 million units of IntronA. With each treatment I was put to sleep and the solution was dripped into the kidneys for two hours. Dr.O'Donnel inserted stints into each ureter (to defeat the one-way valve that nature put there), dripped the solution through the penis catheter, through the ureters and into the kidneys. The solution was then allowed to slowly flow from the kidneys into the ureters and finally into the bladder, thus treating the whole system.
 
In six weeks after the treatments ended Dr.O'Donnell will do localized cytologies on each kidney, each ureter, the bladder and a bladder biopsy to see if the treatments were successful. I again ask for your prayers.
 
I'm optimistic that they will be successful. The tissue lining the bladder is the same as that in the ureters and the kidneys. The treatments worked on the bladder, they should work on the other areas too. Dr.O'Donnell has had good success with other patients with my same situation. In fact, I've talked to a man who lives in my same town who underwent the same treatments from O'Donnell and was clear in his first follow up after his urinary system treatments by Dr.O'Donnell.

Update, October, 2000

John answers some questions from a new member of the discussion group:

>1) Was there any difference in your general reaction to the mixed drugs asopposed to the BCG alone? On webcafe you mentioned that after the first round you were more tired, and had minor headaches and a ringing in your ears. Did anything else happen in subsequent rounds of treatment? Could you take any medication, such as tylenol or tylenol plus codeine if the pain was severe?<

I never had very much trouble with BCG and was also feeling almost normal the next day after the BCG + IntronA instillations. Dr. O'Donnell did the first treatment with 1/3BCG and then dropped it down to 1/10 BCG for the remaining treatments.

>2) With BCG alone I generally missed from work just the day of treatment and was then able to resume normal activities. Was this true for you with the mixed drugs?<

Yes.

>3) You mention the expense involved, with 6 weeks running $7200 - $10,000. I presume most of that is the interferon because from what I've seen the BCG alone is only a few hundred dollars. If you have medical insurance, were they willing to cover it? My sense is that the treatment is considered experimental.<

The Intron A is the expensive drug. At first the insurance didn't want to
cover the treatments. My Dr. wrote a letter to them explaining that if they
didn't approve the next step was going to be a verya very expensive
operation. They agreed to and did cover it.

>4) For your last treatment, with Dr. O'Donnell, you mention treatment of
your entire urinary system, with the solution dripped into the kidneys. Is this Dr. O'Donnell's current recommendation for treatment, or was there
something unusual about your case that led him to try this?<

After the initial BCG + Intron A treatments my biopsy was negative (good) but my cytology was positive. Dr. O'Donnell suspected that either the ureters or the kidneys had picked up the bladder cancer. He treated the kidneys and ureters by inserting a tube in the ureter (to defeat the one-way valve) and slowly dripped BCG + IntronA into the kidneys, let it drip down through the ureters and into the bladder. That treatment was harder on me because I had to be put to sleep each time and the kidneys seemed to revolt some. I felt bad the day of the treatment but was able to fly home the next day and generally felt better the following day. The treatment cleared up the ureters and Kidneys but the follwing biopsy and cytology showed that the cancer was back in the bladder.

I then had 6 bladder only treatments using 1/10BCG+100million units of
Intron A+ 4 million units of IL-2 (Interluken). These were regular
instillations and I tolerated them well. Unfortunetly, the bladder cancer
is still there.

I'm trying one more thing on Dr. O'Donnell's recommendation before I have the operation this December. I'm taking 20mg/day of Piroxicam (generic for Feldene a COX-2 inhibitor)and will take it for 6 weeks. I'm also taking 500 mg, twice a day, of Ciprofloxacin (an antibiotic) twice a day for the same period. I'll have a cytology at the end of the six weeks to see if the bladder has improved. If it hasn't then it's operation time.

Deacon John

PS Dr. O'Donnell has had good success with the BCG + IntronA and has a nationwide trial going on. That trial might be the one your doctor is
recommending.

Update Feb.9, 2001

I did BCG/IFN and then BCG/IFN/IL2 (BCG+interferon+interleukin2). The treatments didn't knock the CIS out but seemed to really slow it down and keep it confined in one small spot. Dr. Marshall is trying Mitomycin C and then will fulgurate the Cis spot when he biopsy's me in May.

Update Apr. 10, 2001

After I had finished my (BCG + IntronA+ IL2) instillations I still had CIS.While I was waiting to schedule the cyctectomy I took 20mg/day of Piroxicam (generic for Feldene, a COX-2 inhibitor) for 6 weeks. I also took 500 mg of Ciprofloxacin (an antibiotic) twice a day for the same period. I also took 3 grams of MGN-3 for two weeks and then one gram for four more weeks.

Then I had a biopsy at Emory hospital which showed that the CIS had been slowed down and confined in one small spot. I don't know what improved the CIS situation. It might have been the prayers, the Piroxicam, the Cipro or the MGN-3 but it was improved enough for the doctor to recommend 4 instillations of Mitomycin C in the hopes of knocking the CIS out. I'll have a biopsy May 1st to see how the Mitomycin C instillations did. I'm still taking 1 gram/day of MGN-3. I feel great and my urinary system is working fine.

Again I ask all for your prayers.
Deacon John

Update February 2001

Finished the final & fourth Mitomycin C instillation Feb 9, 2001. We used ### LINK NOT FOUD ###Dr. Jessie Au's new procedure but used the standard 40 milligram dose dissolved in the usual 40 ml of sterile water rather than dissolving it in the recommended 20 ml.

Had Biopsy & bladder wash cytology on May 1, 2001. Pathology's biopsy report said, "no clear evidence of cancer at this time". I view this as definite movement in the right direction. That one area on the left side had stubbornly remained cancerous through numerous BCG and Interferon treatments is now clear.

The cytology of the bladder wash did reveal some malignant cells. Dr. Marshall will give me a single Mitomycin C treatment, following Dr. Au's procedure (including the more concentrated 40 milligram dose in 20 ml of water) in June. He'll do a follow-up cysto & cytology in August.

I am greatly encouraged. The Mitomycin is having a good effect. Your prayers are having a greater effect.

Update Summer 2002

The following is a letter in which John addresses a reader's questions;

John,

After reading your story in "Tales from the Trenches," I found that your
situation and mine are very similar, though I'm way behind you in
treatment. I was diagnosed in March, 2002 with stage Ta Grade III CIS, with possible involvement of the lower left ureter. I underwent a TURB on April 29th, followed by 6 BCG treatments, which I just finished. After waiting another 6 weeks I'm supposed to undergo another TURB under anesthesia and see where I stand.
________________

John: What made them think your ureter was involved? If the ureter was involved the BCG instillations wouldn't touch it as there is a one way valvue in the ureter that only lets the urine flow from kidneys to bladder.
________________
Reader: You appear very knowledgable about the treatments available, and very proactive in seeking out the most aggressive treatments you can find, short of a cystectomy. I'm inclined in the same direction, but am trying to figure out what to do other than blindly follow my uro's lead. If you don't mind, I would like to ask you several questions to help me find my way:- I am also a patient of Dr. Green, who removed my prostate 10 years ago due to cancer. I have had no recurrence of that, though there was one side effect I would have wished to avoid. Have you been satisfied with Dr. Green's approach to your BC, or have you felt that he was "behind the curve" in treating BC and switched to someone else?
__________
JohnI have high confidence in Dr. Green. I switched to Dr. O'Donnell because he was the leader in treating with instillations made up of BCG + Inteferon (IntronA). Dr. Green, in fact, recommended Dr. O'Donnell's procedure as a way that might avoid cystectomy.
__________
R: Since you've apparently had state-of-the-art treatment, and some of it bordering on experimental, have you found any of the treatments more effective than the others? I have a hunch my BCG treatments are having no effect, because I've had no inflammation or reaction to them at all so far as I can tell. I had two UTI's during the treatments and a lot of bleeding from a stent, but that was it.
_____________
John: Ah, the stent was to treat the ureter with BCG right? I've had BCG alone; BCG + IntronA; & Mitomycin Cinstillations. Each type had a good effect at times and no effect at other times. Sometimes they cleared up the bladder but the cytology came back bad indicating the ureters or kidneys; other times the cytologies came back good but the bladder biopsies were positive.
________________
R: I'm reading a book entitled "The Transformed Cell," by Dr. Rosenberg of the NIH, who developed a treatment for cancer (he didn't try it on bladder cancer) which consisted of a combination of IL2 and TIL (Tumor Infiltrating Lymphocytes) which was 40% effective in curing or at least shrinking advanced metastatic cancer. have you explored that option for your BC or discussed it with any doctors?
______________
No, I've never heard of TIL. That would be a good question to ask the webcafe group. Another book I'd recommend is "The Guide to Living with Bladder Cancer" by Dr. Mark Schoenberg of Johns Hopkins.
______________
R: Is the Dr. Marshall you consulted the Fray Marshall at Emory, who's
listed in the "Top Doctors of America" book? What did you think of him? I'm thinking of getting a second opinion while waiting for my second TURB, and am considering him. Is he accessible to new patients?
______________
John: Yes, it's Dr. Fray Marshall. I think he takes new patients. He came from Johns Hopkins and has a great rep as a urologic surgeon. I like him very much but I don't believe he is also an oncologist like Dr. Michael O'Donnell is. I went to Dr. Marshall when it looked like the cystectomy was my only option. After he examined me he suggested a series of 4 Mito C instillations be given before we looked at surgery.
After those treatments the bladder biopsy was negative and the cytologies were "atypical cells", which is a step above but next to 'negative'. I've had maintenance instillations since then and all have been 'atypical' except the last one which was 'positive'. I just finished 4 weeks of MitoC instillations and will have a cytology done July 9th. If the cytology is negative we will continue with maintenance treatments. If the cytology is positive, he will do a complete work-up on me in the hospital: biopsy, IVP, ureter scope, etc. to see where the malignant cells are coming from. Then he will give me a treatment plan.
_________________
R:How did you pick Dr. O'Donnell for some of your treatments? Is he also a noted uro for BC? I'm not eager to travel for treatment, but if it would give me a better chance, I would do it.
________________
John:He gave me 7 weekly treatments of my ureters and kidneys with BCG + IntronA. He installed stents in the ureters and placed the solution into the kidneys then let the solution drip down through the ureters into the bladder over a 2 hr period. It worked for the ureters and kidneys but the biopsy of the bladder came back positive.
_____________
R: Did Dr. Green put you under general anesthesia for your TURB's and IVP's? The general makes me sick, but he says it's necessary for the procedure.
________________
J: Yes. I have heard that a local anesthesia can be put into the bladder for biopsies but have never had it done that way. You probably can see that I'm undecided as to what to do at this point.
________________
R: While I have no real reason to doubt Dr. Green's credentials for giving me good treatment (10 years without a recurrence of prostate cancer ain't too bad), I have no one to compare him with, and he hasn't really been a fount of information when I ask questions.
__________________
J: Yes, Dr. Green is a man of few words but he will answer your questions. I used to make an appointment with him so my wife and I could talk to him. We would go in with a list of questions and he would answer them.

July 28, 2002
We have such great news, John received his report yesterday and it was negative for any cancer cells. Praise the Lord! Many thanks for all your prayers.

Now we can really relax and continue to enjoy these beautiful Colorado mountains.

Love Carol & John
www.deaconjohn.catholiccompany.com

Sept. 6, 2002

If anyone is a refractory bladder cancer patient it is me. I've had two courses of BCG, two more of BCG + Interferon; two or three of Mito C. While I responded to all of them, eventually the BC recurred. I'm encouraged by the results of the new, somewhat expermental Gemcitabine treatments Dr. O'Donnell recommended that I take. I started the Gemcitabine instillations (2/week for 3 weeks) on July 15th. Cytology results of urine sample taken that day: POSITIVE. I finished the 6th instillation on August 7th. I had to stop after the 3rd one on July 22nd because of blood in the urine and a bladder infection that seemed to be caused by the insertion of the catheder during the 3rd treatment. Seven days of 500mg/day of Levaquin cleared the infection.

Results of August 27th cytology: "No neoplasms present" (ie. NEGATIVE). The cysto still showed some red areas but no frank tumors.

I'll start the second 6 instillations on Sept 2nd.

There are numerous Phase I trials using Gemcitabine as an instillation agent for refractory bladder cancer patients. At Sloan Kettering 7 of 18 patients had complete responses and 4 of those 18 had negative bladder biopsies. At Johns Hopkins 9 out of 13 evaluable patients were recurrance free after 12 weeks. At Univ of Iowa, almost all of Dr. O'Donnell's patients treated with Gemcitabine had complete responses (most relapsed in one year which indicates the need for ongoing maintenance with Gemcitabine or Mito C--this maintenance is being studied).

June, 2004

I finished 12 Gemcitabine instillations--2/week for 6 weeeks. Before I started these treatments my cytology was Positive. My cytology after the 6th instillation was negative and my FISH test was negative after the 12th instillation.

My next biopsy showed that all of my previously troublesome CIS areas in the bladder were "negative" but the prostatic urethera area was "positive" for CIS.

The Gemcitabine didn't get to the prostatic urethera area adequately because that site is between the internal spinchter and the external spinchter muscles. The Gemcitabine couldn't get past the internal sphincter. So during the above biopsy Dr. Marshall TUR'ed the internal spinchter so the next set of Gemcitabine instillations could get to that area.

Six more Gemcitabine instillations followed the biopsy. I could definitely tell that the Gemcitabine was getting to the prostatic urether area.

Another biopsy followed the six instillations. Results: BLADDER AND PROSTATIC URETHERA BIOPSIES WERE NEGATIVE!!!

This June I finished my 5th monthly maintenance Gemcitabine instillations (7 more to go). Had a Cysto 5/28/04 (4 months after last the biopsy). Uro said the bladder looked better than it ever had.

BC buddies: If you are refractory after any of the standard instillation procedures and your Urologist says cystectomy is all that is left, ask him to look into this Gemcitabine protocol.

Deacon Johnl