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MDX-1106 part 2

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

cWelcome to part 2. It should be faster to share info here. The last thread got too long. Texas Wedge asked me to review the criteria for getting into the MDX trial.

First of all it is for metastatic clear cell carcinoma only. It requires a biopsy for confirmation. I have become aware that only 80 subjects are expected to be part of this study. All of them in the United States. The study may be up to 4 years depending upon response. MDX-1106 also known as anti-PD1 and BMS-936558. Cancer cells may avoid being killed by shutting down the immune system to early. This antibody works by stopping the immune system from shutting down and allows it to continue attacking tumor cells. It might also attack normal tissues and is a potential side effect.

There are 3 dose levels. 0.3,2, and 10mg/kg. They are assigned randomly unless you have not had any previous treatments. Then 10mg/kg is the dose. It is given by IV over about an hour once every 3 weeks. Cat scans are every 6 weeks. Qualifications include: good blood chemistry including liver,kidney,white blood cells and platelets,thyroid function, hepatitis and HIV absence. Good physical condition and attitude.

Multiple cat scans, bone scans, brain scans, pet scans and 2 biopsies are required before the start.Tons of blood work. Most common side effects include: fatigue or weakness, rash, itchiness,redness,or dry skin. Diarrhea, protein in the blood, decreased white blood cell count, risk for infection and dry mouth. There may also be liver abnormalities, fever or chills, nausea, vomiting, thyroid abnormalities, shortness of breath, joint pain, headache, muscle pain, loss of appetite, arm or leg pain,cough, post nasal drip,lung inflammation,pituitary gland abnormalities and hair loss. Others include: allergic reaction to the drug,pancreas inflammation, back pain, swelling of arms and legs, heartburn, fluid accumulation in the abdomen, trouble sleeping, excessive sweating and possible risk of death. You cannot be pregnant or be breast feeding.

(Side effects sound like the grocery list of any medication you could take for anything.)

The study can be stopped at any time that your cancer worsens or if you do not tolerate the medicine or side effects. You can also drop out at any time but are required to continue with scans and blood work as required....So there is a committment if you qualify and are admitted to the study. However, I don't think there is a better alternative out there. I'll say it again that I feel extremely fortunate to be part of this study. Hail! Hail! the "Magic Bullet!"

I'll also say that besides dry skin and recent bouts of significant hip, back and chest pain, this has been real easy. I don't expect any further complications. I will also state that I currently feel excellent! Pain free. I am able to exercise and restarted my running. Psychologically I do not let any negative thoughts develope. I always think positive, have goals and plans and don't sit still for very long. Almost 5 months ago I was told that my demise could be in as little as 6 months. Believe me. Not even close. I've already booked a few motorcycle trips this summer. I also expect to play alot of golf.

My suggestion to anyone who may qualify for this study is to persue it. There can't be many openings left. For the rest of you, hang in there. We are onto something great and everyone may benefit from this soon.

Remember, FLY.

Fox loves you!!

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Thanks Fox for an excellent summary and conspectus of your own experience to date. Continuing to hope it will be the complete answer for you. I was hoping it might be a possibility for me too but clear cell only rules me out. With luck it's a major step forward that could benefit many here and elsewhere too.

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

SO much for this information! I asked my oncologist about this and, although he is having his staff check into it, he does not feel I am a candidate. My (remaining) kidney has been cranky (as I call it) - with Creatinine levels too high and a GFR that hovers around 35. Add COPD into the mix and now liver studies going a little wonky (tumor there now too) .... well, can't hurt to ask, can it?

I've started on Sutent now (after stereotactic radiosurgery did not give any results) - so we'll see how this goes.

Again, thanks Fox!

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

4th infusion today. I had been having a lot of pain previously. When I saw the Dr. today and told her I was pain free she gave me a big hug! I look forward to my next scan in 3 weeks. Lets hope these tumors are going away!

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

Hi Fox,

My prayer for you is no tumors and no pain! Riding season is just around the corner and I know you will be ready.

Health and Happiness to all,
Wayne

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Wayne - I don't suppose Fox goes riding to hounds!?

Fox - you are going to be that poster child!

garym's picture
garym
Posts: 1651
Joined: Nov 2009

lb and fox,

You guys never cease to amaze and inspire, your fierceness in battle is awesome!! Your willingness to share and help others along the way goes way above and beyond, from the bottom of my heart and I believe on behalf of everyone hear I'd like to say THANK YOU and keep it up!! I pray that the MDX and sutent are "magic bullets" for you and all that need them. lb, I miss the pooch pic, how about it, got another?

Gary

foxhd's picture
foxhd
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Joined: Oct 2011

..Is there no one else on this drug except me?

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Fox, was that meant humourously? As I understand it, there is only a very small number of people involved in the trial in the US and probably similarly in the UK. The proportion who might show up here is a matter of conjecture but I'm guessing that on CSN the answer to your question may well be 'Yes".

garym's picture
garym
Posts: 1651
Joined: Nov 2009

Nope...right now you are like that first guy that decided to pack up his covered wagon and head west...think of the rush that followed him and, I believe, you soon after. You are a pioneer in every sense of the word, the Rockies did not stop him and RCC will not stop you. Of course he got the gold and all you get is the magic bullet and Al Gore hadn't "invented" the internet yet so nobody could watch his progress the way we get to witness and root for yours.

foxhd's picture
foxhd
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Joined: Oct 2011

Wow! The pressure! the pressure! I better do good. So, I did my weight training and jogged 2 miles this morning. Must admit that I really look forward to my next scan in 2 weeks. I'm gonna get my pom poms out....

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

I was with you in this! From your detailed description, it really does sound like it could be the next great thing - far out-pacing everything that is currently available. I'm finishing my 2nd week of Sutent and although I haven't had some of the WORSE side effects, I'm having enough to make me seriously cranky! Two more weeks - ugh! BUT if it will slow this crap down a bit and I can continue to say LOUD and PROUD - N! D! Y! - I guess it'll be worth it.

BENLBENTLEY
Posts: 6
Joined: May 2012

Hello FOXHD I was scanning the net and found your post about the drug MDX 1106. I am also on a trial with MDX 1106 and it sounds like the same one. Having good reports from my scans and very little side effects. Proverbs 27:1

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

You're right not to tempt Providence by premature assumptions but you must admit it looks pretty good for you guys so far and so it's giving renewed hope to many.

Fox has launched a third thread, astonishingly labelled "MDX, part 3" and you might want to post your very welcome news there too, so that the latest messages about it are kept together in chronological order. You'll get to it at

http://csn.cancer.org/node/236861

Your news bears out Fox's impression that the trial is proving a great success and we all hope for both of you and for future countless others it will turn out to be as good as it currently looks.

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

Has your doctor given any reason for the pain? I ask because I'm just starting 3rd week of Sutent and my pain level is pretty bad. Feels like somebody has been beating on my ribs, chest and upper back with hammers! Making me seriously cranky!

Thanks! And continued prayers for your good progress!

rae_rae's picture
rae_rae
Posts: 264
Joined: Oct 2010

Lb,

Sorry to hear about your side effects! Is that normal with sutent? I read a lot about the hand, foot and mouth sores and fatigue. I know my memory has been really bad this past year but I don't remember reading that! I hope it gets better for you soon. Two more weeks...it will be over before you know it.

Rae

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

I haven't read about this one either - and let me tell you - when you start on this they give you a boat-load of information covering just about everything! As far as the 'known' side effects, I've got the fatigue, sore mouth and extreme indigestion (and the worst of all - COFFEE doesn't taste good! GRRRR).. This pain thing is making me crazy! Doctor has now scheduled a bone scan to check things out. Soon I won't need to use any lamps or lights in my house - I'll light everything up all by myself!

rae_rae's picture
rae_rae
Posts: 264
Joined: Oct 2010

I hope that goes well for you. Just think...if we all got together we would be brighter than the sun!

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Ibinmsp, my pain appeared to have been from bone mets, but I am now pain free.That is why I look forward to my scan in march. Could the mets really have gone away? All I know is that I feel great. Currently, the only other side effects I seem to have are occaisional bouts of fatigue and inflammed hands with peeling skin. Big deal.

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

for your response. As for your question - I'm believing that those bone mets DID go away! This new drug may be the magic bullet so many with MRCC are waiting for.

lbinmsp's picture
lbinmsp
Posts: 266
Joined: Jun 2006

Sorry for double post - my finger got away from me!

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

Hi Fox.. I am not in that trial but was asked to try Everolimus. I am stage 2 grade 1 RCC (clear) Yes I was scared of all the side effect but realize they are the same as many meds even over the oucnter drugs. The one thing that differs with the drug they want me to take is that it also kills good cells. From what I read, Everolimus can increase your risk for not only infections but also increases your risk of lymphoma and skin cancer. That is what is giving me second thought as to whether or not I want to participate. Anyone eles in this treatment with low stage RCC?

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Clinical trials are an interesting thing. The scientists need volunteers to prove or disprove the benefits of new drugs. Therefore, there is a risk that a volunteer might not be given an equal chance at benefitting from a drug. I was offered a votrient trial last year but passed on it because I saw no benefit to me but good chances that I would only be a test subject. Having been offered the MDX trial was different. No placebos. Only a chance for improving if it worked. So far it has worked great! Infusion tomorrow, next scan in 3 weeks.

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Here are 2 more comments. First, I kind of forgot that had I begun the votrient study last year,..(yep!, it's May. A whole year since offered the trial)..then I had the potential miserable side effects and risked spending what was probably gonna be my last summer alive, feeling miserable. I opted to enjoy my last summer playing golf and riding my bike. Good choice because I enjoyed my summer and in the fall found out I might have only 6 months to live.I was a hurting puppy by december and january. Once my trial of MDX started I began my miracleles (sp?)improvement. Minor setback with 2 skin cancers, but they both be gone by next month....So, I went for infusion #8 today. Doctor says blood work is excellent. Tells me that my timing to get into the study was perfect as a couple weeks earlier or later and I would have had to get something else or most likely Interleuken. She says she expects me to live a long life. She says that only 1 in 3 respond like I do and I am the one. She told me how I brighten her day. I told her she can call me "Sunshine" and to call me anytime she needs a morale booster. She gave me another big hug...........So here's to luck and not jumping on the first trial drug being offered if it does not serve your purpose.

sunlover_56's picture
sunlover_56
Posts: 110
Joined: Apr 2012

What what an awesome and inspiring story. I am so happy for you "Sunshine" :-) and I am proud to know you in this forum.. thanks

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Thank you Sunlover. Unfortunately, I can not be a sunlover like I was anymore. I am going to try to delay my melanoma surgery my head a while I do a couple motorcycle trips this summer. I'm thinking my drug will take care of it,..but we'll see......AND..........it is excellent to know you too. That is why we stay on site. To support each other. FLY..
Fox loves you!

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Sundodger here. Fox, shouldn't this be going onto your MDX-1106, part 3 thread? I'm getting giddy trying to get the chronology straight!

Is the 1 in 3 response rate you've been quoted specifically for the trial you're on? If there are others who are responding like you I guess that's great news but I fear there's only one Fox.

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

..But it kind of fell here due to the previous responses. I asked again about how others are doing in this MDX study.. But they are elusive with their answers for confidentiality reasons. But, the way they respond to me, and the body language I receive tells me that I am doing really special. They have a smile, a glow, a sense of goal acomplishment. I can almost see in them that they like seeing me as it confirms why they do this.

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

..But it kind of fell here due to the previous responses. I asked again about how others are doing in this MDX study.. But they are elusive with their answers for confidentiality reasons. But, the way they respond to me, and the body language I receive tells me that I am doing really special. They have a smile, a glow, a sense of goal acomplishment. I can almost see in them that they like seeing me as it confirms why they do this.

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Yes, it must be enormously gratifying for them but still not half as much as for you! I don't suppose BMS are grieving either - it should be about to generate a revenue stream for them that will fund a lot more R & D - good for everyone a real win-win situation.

Limelife50's picture
Limelife50
Posts: 409
Joined: Nov 2011

I always wanted to ask a little more about your cancer.If i remember correctly your original dx was RCC stage 3 also the original scans showed no spread of the disease.But then 6 months later on your follow up scans you were downgraded to a stage 4 due to mets to the lungs and also the bones.I am curious about the original path report relating to grade type size of original tumor and any other characteristics of your cancer since you have responded so well to the MDX treatments.I have always beeen intrigued why some people respond differently than others to certain drug therapies and i sometimes feel the genetic makeup of the cancer a person might have determines the reponse they might recieve from different drug therapies. Thank You Fox

Limelife50's picture
Limelife50
Posts: 409
Joined: Nov 2011

Glad to hear you are sailing along Fox but that Sunshine name seems like you are getting a little soft here,i am just curious if i had met you 2 years ago and called you Sunshine then held out my arms what your reaction would have been.Heck i have even noticed over the last few months even ole Texas from across the pond has evolved into a Big Teddy Bear.Not to stir anything up but i never believed in the word luck,i believe at times some of us have been blessed or a little more fortunate but luck for me is for gamblers

littledarlin's picture
littledarlin
Posts: 102
Joined: Mar 2012

Hi Fox! Reading you post today sure put a lot of Sunshine in my day..I just love reading about how well you are doing..I have visions of you riding your bike cross county this summer enjoying everything life has to offer..My husband was a die hard biker and Lived to Ride as they say..I sure do miss hearing his bike roll up..

Hey! I sure would love to see some pics from your bike trip this summer..If you don't mind..

Till next time..
Littledarlin..

BENLBENTLEY
Posts: 6
Joined: May 2012

I am also in the MDX 1106 trial. Started the trial at MUSC in Charleston,SC Nov. 2011 and have been moved back to Vanderbilt in Nashville,TN where I started the fight with RCC Stage 4 in June,2007. This is my 3rd clinical trial and I have been responding very well to this treatment with minor side effects (joint pain being the worst). Tomorrow I will receive my 10th infusion, the first treatment at Vandy. Do you know any of the other patients on this trial? I am also a golfer and a retired biker after 43 years on the road. May God bless all that are fighting cancer.

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Good to talk to you. In a manner of speaking. First, Nice to see you are 4 years stage 4 RCC. It keeps my enthusiasm up! So far just you me and Alice's husband are on MDX on this board. Her husband has a combo with votrient. He just started. I get my 9th infusion next weds. I've had no previous treatment except nephrectomy in march 2011. My mets were pretty significant by the first of the year. But my response has been amazing. I'll have more to say about this next week as I get another scan this friday. My only side effect is fatigue. But I can work through that. They are watching my thyroid for this since I am generally very active. It seems golf and motorcycles are a common theme here. Or maybe thats just what men over 50 do. I am on the highest dose of 10mg/kg every 3 weeks. Seems to easy . That scares me. Seems the response rate is around 30% And I am that lucky one in 3 at Yale. Keep us up to date. I'll start an MDX part 4 next week.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Welcome Ben. Like Fox said, my husband started the MDX1106/Votrient trial on May 10, so it's a little soon to know about response but we're sure enthusiastic and hopeful. My husband had the HDIL2 treatment prior to starting this trial but his response did not merit continuation. He is a stage 4/grade 4 clear cell, diagnosed October 2011, nephrectomy in November 2011, and HDIL2 January/February 2012.

Sure hope this board keeps the excellent MDX 1106 responses coming. Fox has been our inspiration.

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Alice, have you had any informed comment on latency of effects of the various RCC drugs? They could be expected to vary widely in respect of how soon before they start to take effect (like anti-depressants) and how long after cessation they may still have a therapeutic effect.

Fox - you'd better start MDX part 4 soon or everything will keep going on to part 2 instead of part 3 and the sequence of events will be more and more confusing.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

I have found nothing specific on the latent benefit of HDIL2, but I have it noted as a question to ask John's oncologist next visit.

In trying to research the latent numbers, I again, as I do quite often, come away with more questions than I answer. It made me wonder how John's HDIL2 response would be noted in medical terminology in reference to HDIL2. Initially, his doctor referred to it as a mixed response. 1 MED reduced in size; 3 increased in size; and 2 new meds. I guess an argument could be made that growth would have been more severe without HDIL 2, particularly in light of his uptick in his tumor activity since March 15.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

I have found nothing specific on the latent benefit of HDIL2, but I have it noted as a question to ask John's oncologist next visit.

In trying to research the latent numbers, I again, as I do quite often, come away with more questions than I answer. It made me wonder how John's HDIL2 response would be noted in medical terminology in reference to HDIL2. Initially, his doctor referred to it as a mixed response. 1 MED reduced in size; 3 increased in size; and 2 new meds. I guess an argument could be made that growth would have been more severe without HDIL 2, particularly in light of his uptick in tumor activity since March 15.

alice124's picture
alice124
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foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Lets end this thread unless indicated. Part 3 is going to be pulled up. Part 4 begins next weds, or thurs. Thanx. Fox.

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