Rituximab Clinical Trial for UC - Paging Tex and Polly

hoosier1 · Post by **hoosier1** » Sat Jan 08, 2011 2:22 pm

Marliss and Tex and all,

I find this study to be very interesting. Marliss, they are trying Rituxan for IBD (UC).

http://clinicaltrials.gov/ct2/show/NCT0 ... tis&rank=6

Rich

MBombardier · Post by **MBombardier** » Sat Jan 08, 2011 2:46 pm

VERY interesting, Rich! I will have to ask my father if he sees any difference in his bowel habits during/after his treatments. The Rituxan he gets is by IV in the hospital, four treatments a week apart. The first one always takes longer because there is a normal (!!) allergic reaction that makes his throat start to swell, so they have to back off and switch to IV Benedryl until the symptoms cease. After the treatment, he comes home and basically just goes to bed for 12 hours. That's the only aftereffect.

It is pretty amazing, how easy the treatment seems to be on the body, but what is the most amazing to me is the results of the very first treatment he had in 2004. He had a fist-sized lump on his upper arm that had been radiated until there were a couple of large sores, and there was lots of redness and swelling. The next morning after the treatment his arm looked like weeks of healing had happened overnight. Even the sores were almost healed over. It was like a miracle.

The question I have about Rituxan and UC would be... the first repeat my father had to have of the treatment was close to four years later, then less than two years later, and now he is supposed to have it every six months whether anything shows on the CT-scan or not. What efficacy over time do the researchers expect to find, I wonder?

Post by **tex** » Sat Jan 08, 2011 2:50 pm

That sounds like a pretty drastic treatment.

Tex

hoosier1 · Post by **hoosier1** » Sat Jan 08, 2011 3:22 pm

Marliss and Tex,

Actually, for treatment of NHL, those are very mild side effects compared to conventional CHOP chemotherapy. Conventional treatment includes high doses of prednisone (the P in Chop), Adriamicyn (sp?) which is nasty and held back as a last resort, and other toxins. Plus, Rituxan has show to be effective in those who are chemo-resistant. I know that my wife had serious D from conventional chemo. If they had such a trial for IBD, I would be eager to be a candidate. The fact that it appears to be in Phase II/III means they have established optimal dosing and are simply testing that does on a larger population of patients.

Marliss, it would be interesting to know how your father's GI reacts to the therapy, but since he does not have IBD (I assume), the point may be moot. So how does one gain access to data regarding those be treated with Rituxan who ALSO have Lymphoma???????

Marliss, just an FYI that your father is probably a candidate for Bexxar or Zevalin. When that monoclonal antibody is conjugated with radiation, the remissive effects are much, much stronger. This has been proven. Even my wife saw a partial response once they infused the radiation. There are many cancer fighting weapons in his arsenal yet to be deployed!

Very interesting!

Rich

hoosier1 · Post by **hoosier1** » Sat Jan 08, 2011 3:26 pm

Marliss,

When the humanized monoclonals hit the market (sorry I have not kept up on their progress), patients like your father will have little or no side effects and no need for Benadryl. I witnessed this first hand. It is the "mousy" portion of the current antibody that causes that reaction. For my wife, she had an anaphylactic reaction in Phase 1 trials. At first, we didn't know what was happening. It occurred a day after infusion. When we called the inventor and lead physician and University of Michigan, he told us what was happening and to get her to a hospital immediately. Her delayed reaction was quite unusual so they still track her health to this day. This was the event that made her ineligible for non-humanized monoclonals.

Regarding the shorter intervals of his remission on Rituxan for your father, it is because of the transformation of the disease. Hence, the radio-labelled versions on the market. Something he SHOULD discuss with his doctors if his remissions are growing shorter. The radio-labelled monoclonals have the promise of a durable if not permanent remission, hence their development.

Regarding its effect on UC, I have no clue. Because I don't yet understand how it targets IBD as it does Lymphoma. I just find it interesting that research is going on in this area. I makes me feel somewhat hopeful too.

Rich

MBombardier · Post by **MBombardier** » Sat Jan 08, 2011 4:09 pm

Thank you for this information, Rich. I think my father really likes his oncologist, though he calls his GP "Fat Boy", lol. I don't like it that they are doing the treatment every six months even with nothing showing on the CT scan. I asked my brother why they didn't just do CT scans closer together and postpone treatment until something showed up, and he said he was wondering the same thing. It may be because the way the lymphoma manifests itself in my father is unique. His oncologist wants to write him up, if he hasn't already.

I am going to give this information to my brother, who will be staying with my father during his next treatment starting in a couple of weeks. He might do better talking to my father about it in person than me trying to talk to him over the phone.

Thanks again...

hoosier1 · Post by **hoosier1** » Sat Jan 08, 2011 4:27 pm

Marliss,

I have learned that the reading of CT scans can be subjective when trying to assess Lymphoma or any systemic cancer progression. My wife used to work for the head of radiology at the hospital where she worked so i developed a special rapport with him. He would sit me down personally, over lunch, and teach me how to read my wife's scan. Great man! I miss him and his help.

The reason why CT scans can be subjective for nominal changes is because the cellular death of cancer cells due to treatment can leave "scarring" for lack of the proper terms. These shadows show up on CT and can confuse the radiologist.

So I am guessing they are simply trying to take the safe route with your father. The changes, if any, might be difficult to discern. But a question about a radio-labelled therapy is in order IMO.

Good luck and prayers to you and your family,

Rich

MBombardier · Post by **MBombardier** » Sat Jan 08, 2011 7:59 pm

Thanks, Rich, that is very interesting about CT scans. I will pass that info on to my brother, along with the rest. You have done us a good service today. Thank you!