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*Nivolumab / Votrient Clinical Trial for One Putt (aka MDX 1106, BMS936558) UPDATE

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

  May 6, 2013 Update

John had his May 2 infusion and is back on schedule with Votrient dosage (800 mg) and Nivolumab infusion every three weeks. He has been experiencing some nausea over the past couple of weeks. Hard to believe but this Friday, May 10, will be John's one year anniversary in trial.

 

On another note--yesterday, May 5, 2012, we walked in our second National Kidney Foundation walk at the Maryland Zoo. The walk raised almost $315,000!

 

 

 April 17, 2013 Update

John had scan today which showed reduction in the ground glass nodule, but Dr. Hammers decided John should skip tomorrow's infusion. Next infusion will be May 2.

 

But GREAT news from the latest RECIST report--tumor burden reduction now at 57%!!!! 

 

 

April  12, 2013 Update

 John’s mouth sore has cleared up  and gum bleeds under control. Back to Votrient 800 mg.  Labs and scan  were done yesterday (4/11/13). Infusion scheduled for today  but postponed due to yesterday’s scan noting “new small irregular ground glass nodule in lower left lobe that may be inflammatory.” Dr. Hammers concerned this may be pneumonitis, a serious (sometimes fatal) side effect of Nivolumab.  However, he feels it is a grade 1 low level infection and has prescribed antibiotics. We will meet with doctor again in a week (April 18).  The good news is scan did not note any tumor growth.

 

April 1, 2013 – Votrient Side Effects/Gum Bleeds – Mouth Sore

Today—for the first time in 326 days—John (one putt) will not take his Votrient pillls. Dr. Hammers made the decision to pull him off the medication (Votrient) temporarily (3-7 days) to allow his mouth time to heal. He’s been experiencing gum bleeds and has a nasty mouth sore that has been giving him trouble over the past week+. He also has a dentist appointment on Wednesday to see if the sore is actually an absess and to rule out osteonecrosis (ONJ).

He’s a little disappointed to interrupt his *record as he takes great pride in his continuous dosage. (*According to his research nurse he’s the only trial participant that hasn’t taken a break from Votrient/Pazopanib.) But he/we know how fortunate he has been up to this point.

 

January 16, 2013 Update on John's (one putt) Nivolumab / Votrient Trial

John had his 36 week scan on Wednesday, January 16. Scan basically showed stability since last scan. But the report came with an initial gasp as his nurse noted what she considered good news: “John’s liver tumor had decreased in size.” That wasn’t particularly well received as John didn’t know he had a liver tumor. After John questioned this, Dr. Hammers confirmed his belief there is no liver tumor and that the radiologist’s comment on the report was not a cause for worry.

Overall, John and I are extremely happy that he continues positive results from the Nivolumab/Votrient trial. John hasn’t posted these results as I believe he’s experiencing a little guilt. Keeps asking why he continues to get positive results when so many aren’t as fortunate.?.?

 

MEDSCAN MAN – hope you are around to comment and make sense of the liver question. This is what is noted: “Abdomen: In the arterial phase inferiorly in hepatic segment 6/7 a 4.7 mm enhancing lesion has been decreased since prior studies measuring 8.8 mm on the study of 8/1/2012.”

 

December 1, 2012 Nivolumab ( new official generic name for BMS936558 - MDX-1106 )Liver Issues

John's liver enzymes are a little elevated but not seriously so, not enough to pull him off the trial. But the elevated liver enzymes issue has been a factor in many of the patients in this trial which is why I understand they are not continuing the votrient/nivolumab arm. The people that are still on the trial (only 18 I last heard) will remain on it as long as they achieve positive results or stabilization unless the liver enzymes become a bigger issue for them.

Thanks for your suppport Ange. If he has to discontinue this trial, we'll look into other treatments or trials. I personally would love to see him get some relief for the shoulder mets and wonder if the cabo trial might be in his future. Other than this trial (votrient/nivolumab), his only other treatment has been HDIL2. So that leaves many doors unopened. We just have to continue to look at this as a chronic disease, not a fatal one.

 

October 24, 2012 BMS936558* Votrient trial (formerly MDX 1106) John's  24 week scan

Wish I had better news to report but I'm not complaining. John had his scan today and it showed stabilization, basically no additional shrinkage, but, more importantly, no growth.

While he was awaiting his scan, his research nurse (the dear Monica) talked to him about Afinitor as a possible next step if his scan showed growth, but since it's stable, he will remain in trial. Next scan will be in 12 weeks. Will keep our fingers crossed for continued stabilization.

 

September 21, 2012 BMS936558* Votrient trial (formerly MDX 1106) John's 18 week scan

John had his third CT scan on 9/12/12 since being on the MDX1106 (BMS936558)/Votrient trial. We received the RECIST (Response Evaluation Criteria In Solid Tumors) from the Radiologist this morning showing total shrinkage to date to be 46% (31% shrinkage first scan; 11% add’l. second scan; and 4% add’l. third scan). While we would have loved to see another double-digit reduction, we’re thankful it’s still moving in the right direction.

 

August 3, 2012 BMS93558* Votrient trial (formerly MDX 1106) John's 12 week scan

went with John to his doctor’s appointment yesterday and I brought up his thyroid/medication levels and questioned his need to stay on those meds. The oncologist agreed it was reasonable “to stop the medication for six weeks and see where we are at that time.” So John has one less drug to take for now.

He also had a CT scan. As most of you know, John is on the Votrient/BMS 936558 (MDX 1106) trial and his previous scan on 6/20/12 showed a 31% reduction in tumor burden. It appears that his improvement is continuing though I don’t have a percentage of reduction yet. The percentage number comes days after the scan from the clinical trial sponsors. I’ll post that when it comes.

Two of the impressions are noted below:
1)Interval decrease in multiple pulmonary nodules with some nodules remaining unchanged, no new nodules.
2)Interval decrease in destructive metastatic lesions of the left ilium and right glenoid.

One other impression caused us some concern, though his doctor isn’t too worried about it. Said it could be side effect of medication and something we will watch.

“4 mm focus of arterial enhancement in segment 6 of the liver which is hypodense on

July 15, 2012 Brief 9-Week Update

John had his nine week infusion on Thursday (BMS93558) and had bloodwork, ekg, etc.

The bloodwork was overall okay with alkaline phosphatese still elevated - still bouncing around. A month or two ago it was over 800 now it's at 325,but it was 250 three weeks ago. I believe the optimal number for this is between 30 and 120. They attribute the elevation to bone involvement, but intend to do nothing about it right now.

One liver function test--alanine amino transferase--is slightly elevated which could be a side effect of the Votrient/Panzopanib. The thyroid test also was low (0.05), even after lowering the thyroid medication last visit. They've cut it in half for the second time and will continue to monitor. To be honest since it's lower this time than it was last time when they cut it, I wonder why they just don't stop the medication, but they certainly know more than me. I hope this can somehow explain his lack of energy overall.

His red blood cell count continues to climb but still below normal (2.12). His platelets also are little low, another possible side effect of Votrient.

He also is going to back to his primary doctor after finding a first degree heart block. They will let him determine if John needs to see a cardiologist.

 

June 20, 2012 BMS93558* Votrient trial (formerly MDX 1106)

John had his six-week CT scan today. For those of you that are unfamiliar with John’s history,see below for quick update.

The scan showed SIGNIFICANT interval decrease in the size of multiple pulmonary metastases with no evidence of new lesions. There also is a decrease in the pelvic and shoulder regions.

The research assistant who walked him through the tests today was thrilled. She said with this much improvement in six weeks, she can’t wait for the twelve week scan.

 

May 10, 2012 MDX 1106/Votrient Trial

Okay, we're back on for May 10. EKG's went okay. Since the blood work showed no red flags, the fever and wbc count is being attributed to tumor fever. His thyroid count is low and he will receive medication to bring that up and hopefully restore some of his energy.

 

May 3, 2012 MDX 1106/Votrient Trial

Yesterday didn't go perfectly. John's been having terrible pain in his shoulder for several weeks now. Yesterday his scan showed bone lesions, growth in his lung nodules, and a pelvic mass. His EKG was a little high (457) and he had a fever and an elevated white blood count. His EKG must be below 450 to qualify for trial and they are going to do another EKG tomorrow. Their thinking is the fever and elevated WBC may be attributed to tumors and his ingestion of nausea medication prior to the EKG.

If EKG is below 450 tomorrow and there are no more setbacks or red flags, he will begin the trial on May 10. He and I are very anxious to fight this disease and have been in a hold mode too long. Fox has had great results with MDX and we're hoping to join him on the winning side of the field. Keep me posted on your plans so we can compare notes.

 

May 1, 2012 MDX 1106/Votrient Trial

 John will be at Hopkins tomorrow being screened for admission to the MDX 1106/votrient trial. Oncologist's office told him to be prepared to be there all day with tests - blood, ekg, stress, etc. He's concerned about stress as he's been miserable with sholder pain for a month now. (Doctor prescribed oxycodene a couple of weeks ago but hasn't helped much.)

If screening goes okay, he'll start trial on May 10. Then on May 11, they have scheduled an MRI of his shoulder.

_________________________________________

Johns History at Johns Hopkins:

After weight loss for several months and then the development of cough, on 10 /14/11 met with internist at Johns Hopkihs and diagnosed with Kidney cancer clear cell/grade 4/stage 4 – with sarcomatoid features and lung mets; also has soft tissue mass in shoulder area and pelvic area.


11/1/11 – Surgery for removal of right kidney (nephrectomy)

Treatments to date:
January & February 2012 -HDIL2 treatment/first round 14 doses/2nd round 10 doses;
(discontinued after February 2012 as scan did not merit continuation)

 

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

Previously massive shrinkage in volume; lately a brief break, off Votrient, and still no growth - it sounds very good to me.

Congratulations to you both!!

angec's picture
angec
Posts: 621
Joined: Mar 2012

Alice, sorry to hear abou the "minor" set back, but the news is still GREAT!  In the meantime a little break is good for the body.  This way the body has time to refresh itself a bit.  Please let us know next week if things have cleared up with the lung. Do they have to scan again or can this be seen on normal xrays? I hope John is feeling good inspite of it all!  All my love to you both.. enjoy the spring!!  XXOO <3

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

He will be scanned Thursday morning prior to seeing the doctor. Dr. Hammers seemed to be concerned about the infection and pneumonitis, but he was adamant that--as far as the cancer front was concerned--John was doing great. When he saw John to tell him that he wasn't going to have the infusion this past Thursday, he had two assistants with him. John said he asked him to hold out his arms. John did and Hammers said to his sidekicks, "This guy was skin and bones when he got here--his flesh was hanging off his skin. Now look at him." John said when he had asked him to hold out his arms, he thought he was observing his shoulder, but he wasn't. He was bragging about John's  gaining weight and muscle tone. 

 We're both looking at it as just a minor setback and feel fortunate it was caught early. Hopefully, Thursday's scan will clear the way for the infusion.  Thanks for the love and good wishes.

How's mom? Been thinking of you and her and hope she is continuing to do well.  Give her a hug from us.  

angec's picture
angec
Posts: 621
Joined: Mar 2012

Hi Alice, glad to hear that John's doc was bragging about his weight gain!  I wish my doctor would brag about mine! ;)  That is very good!  The antibiotics should have already kicked in I hope.  Will he still infuse him although it is only recent he had this issue? He doesn't think he should skip a couple of weeks?  I would probably want to do this since the cancer is doing very well, a couple more weeks can't hurt. But i am not the doctor. Just think it is good to heal a bit more, esp. if this is a side affect.  Is John feeling good though in spite of it all?  You must be cooking up a storm!  :)

 

Mom is doing ok.  Thanks for the hug, gonna squeeze her good tomorrow when i see her.  She is back on 200 mgs. after taking a nearly three week break.  She used that time to get bak to her old self and she was her oldself and it was great!  But now back on she is tired and can't taste good again so i am sure she probably lost some weight again. She is not eating. I am also concerned about the dose of onlu 200 mgs.  She was on 400 mgs before. Although, TW was kind enough to send me an article of a woman who is on 200 for a while and her cancer was stable and no new growths.  That was a pleasant surprise. I hope the same for mom because she certainly tolerates this dose much better than the 400.  Bless her heart!

 

Please accept two big hugs, one for you, one for John!  MUUAH!  xxoo  Love your positive attitude, the only way to go!!

tacyarts
Posts: 73
Joined: Apr 2012

Ya gotta keep your heads up and stay positive Alice . I think of you all often and hope you all are happy. I have been taken out out of study all together because of all complications but still trying to stay positive.

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

So glad to hear from you David. We so wanted to commiserate with you when we heard Monica was leaving us, but she was adamant about handling it one-on-one. and we respected her wishes.

I'm so sorry that you're out of the study. What's the next step? Has your surgery alleviated the pain you were experiencing?

Please let us know what's going on. I'm sure John and I aren't  the only ones interested, so perhaps you can start a new thread on life after nivolumab/sutent trial. Are you taking a new medication? Still at Hopkins? Is there a new trial in your future? We care David.

 

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

Thanks for the update Alice,overall it sounds good

tacyarts
Posts: 73
Joined: Apr 2012

I was on the mdx/ sutent trial But I had so many probs with my leg I just think Bristol just pulled the plug. Dr hammers and I feel that the sutent was working and not the mdx, so I am going to continue to take the sutent and see what happens. I had 25% total reduction but they booted me??? 

angec's picture
angec
Posts: 621
Joined: Mar 2012

David, sorry to hear you are done with the trial. It is ok, I am sure there are other options for you ahead. Great you are keeping positive, that is the way to go!  There are alot of new drugs out there on the way that are very, very promising. I am sure you saw the link that DBS posted....on the things up the  pike..  check it out  and please let us know how you are doing.. When one door closes God opens a window!  ;) Stay strong and here is a big hug!!!  XXOO

AprilandChuck's picture
AprilandChuck
Posts: 95
Joined: Feb 2013

Tell John he is not bragging when he talks about how well he is doing and please tell him never feel bad about giving the group good news.. a lot of us.. enjoy so much hearing how well some are doing .. it inspired hope :D and I hope his next scan shows that it is okay for him to continue!!! and praying real hard... that your news and experiance remain positive.. and inspiring...I love reading your posts Alice, as a fellow caregiver who has been at this longer than me.. It helps.. thank you!!

one putt
Posts: 72
Joined: Sep 2012

Alice edited the thread on my status with today's good news but it didn't move it up. I'm posting to give it a shove. 

AprilandChuck's picture
AprilandChuck
Posts: 95
Joined: Feb 2013

Thats great news :D  congratulations...May 2nd is not a long wait either for your next dose...you all are an inspiration thanks for sharing :D

KJones1969
Posts: 158
Joined: Mar 2012

Great news for John! Even with the very small set back you keep getting great news. I don't get on here as much anymore but love to see how you guys are doing. Fight the good fight and I am thinking of you both.

foxhd's picture
foxhd
Posts: 1873
Joined: Oct 2011

I think the biggest difference between our response to the MDX trial is that you get the votrient and it gives you more side effect issues. I don't have those. Keep getting better. You deserve it.

David, hopefully you'll find a better trial. Good luck.

Fox

I am alive
Posts: 218
Joined: Jul 2012

AlIce,

   I know it's nerve wracking when they temporarily take you off the meds. You automatically think of every terrible thing that could happen in their absence. But if the doc's not worried, try not to be. It's interesting that John is one of the very few - or is he the only? - in the trial who have not taken an drug vacation yet. He's one tough hombre. I recently had a 5-day vacay imposed on me due to a tachycardia incident and I gotta tell ya, it was a refreshing respite. I hope John ends up feeling the same about his.

 

toolman1's picture
toolman1
Posts: 44
Joined: Jul 2012

Wow, congrats on the trials progress, and Alice, I commend you on the timeline organization. You folks are much further up the road of diagnosis, and treatment than I am, and you're organization inspires me to do the same, before the memory clouds, and dates, and treatments become jumbled up. Keep up the good fight, both of you. You both inspire me. Gary.

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

Gary, CSN is a very good site and I think few appreciate just how good, because they don't explore it enough. 

I can't say how many of us use it but the blog facility is a very useful provision - have you considered it?  You get immediately to someone's profile pages (incl your own) by just clicking on their avatar pic or  name.  Once there, the menu at the top has two options at the right-hand end, both of which I use regularly - 'Expressions' to store photographs and 'Blog' to keep a record of medical history and results. I find it handy to distil down my labs reports and scan results, consultations with my Oncologist and GP - all in chronological order as they occur.  I think other members might find it helpful to use the Blog facility to keep their own medical house in order?

toolman1's picture
toolman1
Posts: 44
Joined: Jul 2012

Thanks for that info. Didn't know about that feature. I will investigate it. Gary

Parforthecourse
Posts: 4
Joined: Oct 2012

I have been on 800 mg of Votrient since September of 2012 for my Stage 4 clear cell lung mets RCC.  I also hope to keep it going! I have not had any sores in my mouth but so many liquids and foods are intolerable due to a burn on my tongue.  Does every else have this? It makes food choices difficult.

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

Parforthecourse,

Sorry to hear you're experiencing tongue burns. I'm not sure if that is specifically addressed in the thread, “ Votrient Side Effects” because there’s a lot of information there. I know mouth sores, appetite, etc. have been covered but so have many other side effects that you probably will be interested in reading. In fact, I’d suggest you copy and post your question there. The other Votrient patients will see it there; I doubt they will here. Good luck to you; see you over there.

 

vtvickil's picture
vtvickil
Posts: 17
Joined: Jul 2012

Parforthecourse......

I think everyone gets a little something different with the side effects.  Rick has no mouth sores but his teeth are now extremely sensative to cold.  Though that may be related more to the high dose steroids he was on rather than the Votrient.  Ice cream, cold drinks, even things that are overly sweet are all out for the moment.  He's even brushing with hot water these days.  Have switched to sensodyne toothpast but that doesn't seem to be helping much.   Hear they have a new one out that protects the enamel a bit more.  Will have to give that a try.

Hope your issue subsides soon!

Vicki

vtvickil's picture
vtvickil
Posts: 17
Joined: Jul 2012

Hi Alice

Have been thinking about you and John - was so glad to read that John is still in the trial and (mostly) doing well with it.  The Ground Glass thing stinks but shouldn't knock him down for long.  Be aggressive with the treatment though - not something to mess around with.  Rick is out of the trial and after a pretty horrific winter is back on 800mg Votrient.  Scans in a few weeks will tell us if it is doing it job.  Hammers tried pretty hard to keep Rick in study but I guess with pneumonitis AND two rounds of pneumonia (2nd one nearly deadly) it was more of a risk than they were comfortable with.  We miss seeing you all in clinic but are cheering you on and hope that John continues to have much success!  The sooner this stuff gets approval the sooner Rick can get back on it - not that it's all about us or anything....Sending big hugs!

 

Vicki

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

  

Vicki,

So very glad to hear Rick is back to a routine and not being treated from side effect to side effect. You guys have had an awful run. I just hope that the bad stuff ends here and there’s nothing but blue skies and rainbows from here on out.

John and I just went in and searched “Caring Bridge” for any updates this past week, looking for new information about you guys, hoping all was okay. Thrilled that you checked in and answered our questions.  Here’s to clear scans in a couple weeks. Right now, I think John’s next appointment is May 2nd.  Maybe we'll still run into each other down the road.

 

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