Trial news: The FDA had put a hold on accepting new patients for the Phase III trial for hormone resistant patients, pending investigation of manufacturing methods, which has now been lifted, and it looks like Dendreon is again accepting new participants.

A press release from Dendreon gave an upbeat analysis of the results to date.  The patients were separated by gleason score. My Gleason, according to Dayton, Ohio area pathologists, both biopsy and post-op was reported as 6 (3+3). Therefore, I should be a good candidate for success.

By my interpretation, I haven't had progression over 5 months time, and if it holds true in September, it will be 7 months (hope-a, hope-a), which should put me in the"favored" group. I have had no side effects from the treatment -- I feel physically the same now as I did before starting the program.

 As we all know, nothing works for everyone, and I have certainly failed to benefit from several treatments following indications of HRPC status.

 Maybe this is the one that will work for me. At any rate, I do believe that the final control of this disease will come from some kind of vaccine, gene manipulation, biological control, anti-angiogenesis, etc.

In the meantime, I'm taking my supplements, eating right, getting exercise, and keeping my spirits up, trying to hang on until that day comes.

 Most recent bone scan results:

 7/8/02 Impression (compared to previous scan on 5/15/02):

 1. Current improvement in previously noted metastatic lesion in margin of left scapula.*

2. No change in previous focus of increased activity at T7.

3. Development of an increase in activity in body of sternum which may represent a new metastatic lesion.

4. Net effect: no significant change in the underlying metastatic disease process.

 * I acquired this lesion by January of '93 following RRP on 5/28/92 with favorable post-op pathology reports. PSA at time of surgery was 36, so [I think] they should have known that the PCa was already systemic.

Water under the bridge. Lesion never gave me pain, only some discomfort which I originally thought was muscular in origin, until it became more or less chronic. This discomfort disappeared, never to return [so far], shortly after I started CHB2 in July, '93, even though over time it seemed to increase somewhat in size. All bone scans subsequent to starting CHB until starting Provenge trial indicated no spread to new sites, and since 10/97 they all indicated that the lesion was "stable."

 So far I have had a baseline and 3 follow up bone scans while participating in the trial. They have also shown other areas of activity that are deemed either arthritic in origin or old traumas from fractures (which I can verify). I have no pain or discomfort that I can associate with metastatic PCa.

 So far, I think I am benefiting from the Provenge vaccine, which seems to be causing some regression of the long-standing lesion on my scapula, and over-all stability of the disease.

Next bone scan will probably be September 4th or September 9th.

 My best to all,

/jack

From: MahlonBeav@juno.com [mailto:MahlonBeav@juno.com]
Sent: Monday, October 28, 2002 3:53 PM
Subject: Re: [hrpca] provenge

 

I completed the "therapy" phase in early February, and have had 4 bone scans since. Here is a summary of the bone scan results.:

 [] 2/28/02 seemed to show some regression, but on my closer examination seems to be only "stability" in the metastatic lesion on my left scapula which I have had for 9 years, because I don't believe the other areas that showed regression are actually of metastatic origin.

 [] 5/15/02 showed progression in the scapula met, which "might" be caused by flair due to chemotherapy within the past 3 (or 6) months.  Of course I had no chemotherapy, just the vaccine.

 [] 7/8/02 showed regression in the scapula lesion, but also a new spot on my sternum which was felt to be metastatic.

 [] 9/4/02 showed progression in the lesion in the left scapula, progression in the lesion in the sternum, a new lesion in the left 9th rib posterolaterally, and a new lesion in the intratrochanteric region of proximal left femur, suspicious for metastatic disease. 

 Unfortunately, this progression was not enough to break the blind, so I still don't know for sure whether I received the vaccine or a placebo.  The site in Columbus is urging me to have at least one more bone scan before starting an alternate therapy (I had planned to try AG(aminoglutetamide - Cytraden)+HC(Hydrocortisone) again, which had worked for me previously for nearly 3 years, and I have already obtained a supply). 

 This has presented me with a dilemma.  If I have further progression (which I don't want), it may be enough to "break the blind" -- and if I was one of those on the placebo, I would be able to get the real vaccine on a follow-up trial because they have saved my dendritic cells for this possibility.  I would, of course, do this. 

 If I start the AG(aminoglutetamide - Cytraden) +HC(hydrocortisone), I won't be able to find out if I was on the placebo or not.  Maybe I would be able to in a couple of years after all the trial results are finalized, but if I had the placebo, I wouldn't be eligible for the follow-up trial any more.  Thus the dilemma.

 I have decided to go for the next bone scan on 11/25, and in the meantime have started on Fred Eichhorn's CELLECT vitamin program, which may have some benefit and won't disqualify me from continuing on the trial.

 My tea tag this afternoon reads:  "Success is a journey, not a destination."

 /jack