- This topic is empty.
November 14, 2014 at 1:09 am #22244
As per my previous post, I am going to post updates on this thread about my experience with this trial. After being diagnosed as Stage IIIc in June 2013, I had several surgeries to remove melanoma from my right foot and the lymph nodes on my right leg. Since Sept 2013, I decided to “watch and wait” and have been NED. In Oct 2014, I was informed that the melanoma has traveled to my lungs and I am now officially in the Stage IV Club.
I am literally only 10 days into this so far but wanted to share the details before I forget them. I don’t know if anyone else out there is participating in this trial but please feel free to add your comments to this thread. And by all means, I am happy to answer any questions I can (on this thread or privately) based on my experiences during the next 12 months or so.
After several considerations, I am now officially participating in a new drug trial listed as “MEDI4736-1611”. For more information, you can google either “MEDI4736” or “MEDI4736-1161”. I am in Cohort B at Mount Sinai Cancer Center in Miami Beach.
In essence, it is a combination of an unapproved immunotherapy drug called MEDI4736 from AstraZeneca with an FDA-approved drug called Trametinib from GlaxoSmithKline. I get an intravenous infusion of MEDI4736 every two weeks and take one oral dose of Trametinib daily. The MEDI4736 is an PDL-1 inhibitor while the Trametinib is an MEK inhibitor.
After a massive battery of tests, I started this program on November 4th. I had to have another lung biopsy, as required by the study. Also another CT. Also a slew of blood work. Vials and vials and vials. So far, side effects are minimal but the doctors assure me that these drugs work on a progressive basis and the effects are not immediate. The biggest issue has been the battery of additional scans and a 2nd lung biopsy. The lung biopsy hurts for a couple days since they go in through my back with a long needle while guided by a CT machine. I also have to give between 13 and 17 vials of blood each week which makes for sore arms. I had to do this before Tuesday, then again on Tuesday, then again on Wed, and then again on this past Tuesday. I look like a heroin junkie most days, with sexy black and blue vein punctures. I guess that mild fatigue and diarrhea are the two typical side effects, both from the Trametinib. Also, supposedly a rash is common but nothing yet. Maybe I have a little fatigue and some stomach discomfort. I honestly don’t feel any more tired than normal. And I have not gotten any diarrhea yet either. I just hope this immunotherapy has a positive effect on the cancer. I can handle anything if it kills the cancer. I guess time will tell.
Logistically, I get an infusion of the MEDI4736 every 14 days for 12 months. I go into the infusion area to receive this. It is given in a standard I.V. format into a vein in my arm. No permanent “port” required, which is nice. It takes about 60 minutes for the I.V. to go into my body. As it goes in, they check my blood pressure and temperature every 15 minutes to make sure I am not having a bad reaction. I have only had one so far but I did not feel anything special from it. I am then required to stay there for another 3 hours afterward for observation and more blood pressure and temperature checks. Every day, I have to take one pill of Trametinib. I have to keep it refrigerated at all times for some reason. Again, I don’t seem to feel anything significant from it. I just hope the “magic juice and magic beans” (as I call them) are working in my body and killing the melanoma that has moved into my lungs. When you read the early results from other MEDI4736 trials, soft tissue metastasis like the lungs have been very responsive to this drug. Fingers crossed.
I wish you all well in your journeys on this road.
All the best…
MattNovember 14, 2014 at 4:40 am #65820tamieParticipant
Thank you for the detailed post. I do hope you will continue feeling good, and that it works. We are all interested in learning how it wors so keep update us. Good luck TammieNovember 19, 2014 at 9:07 pm #65821 Hi Everyone…
I just had my 2nd infusion on Monday. So far, so good. Side effects have been minimal and I just hope the medicines are working, the T Cells are doing their job, and the cancer is getting what it deserves.
The process was pretty standard. In addition to the typical 13 vials of blood for testing, there was another dozen or so vials for other testing. The infusion itself was relatively straight forward. Other than the metallic taste in my mouth and elevated blood pressure readings, it was standard stuff. The infusion takes about one hour. And then you have to remain there for three more hours of observation for temperature and blood pressure. It makes for a very long day with labs, oncologist appointment, infusion, and finally monitoring. I just hope it is all worth it.
Side Effects have been relatively minimal so far. However, the doctors and the research staff have repeatedly said that the effects should be cumulative over the first couple weeks. I have a light rash on my scalp, face, chest, and back. I feel like an adolescent boy again, dealing with acne-like symptoms before prom. I have been given a topical antibiotic for it so we will see if this gets rid of the rash. It seems more like a poison ivy rash than pimples. Also, for the 24 hours after the infusion, I had gas which ended in a nice bout of diarrhea. This subsided after the first day and my stomach is now back to normal. According the staff, the rash is from the Trametinib, so I have been reduced from 2mg per day to 1.5mg per day. The stomach issues are from the MEDI4736 but only lasts one day. I have not experienced any other potential symptoms like fatigue, nausea, or disorientation. All in all, I am very happy and hopeful so far.
I send my best regards to all of you who are continuing with the fight…November 19, 2014 at 10:55 pm #65822
Thank you so much for posting your story. It truly helps everyone here, including me to help others as well! Keep up the good work and hope this trial works well for you!November 20, 2014 at 1:07 pm #65823BNP68Participant Thanks for the great updates Matt! I’m very hopeful for you. Sounds like a great trial.
BrianDecember 17, 2014 at 3:26 am #65824
Great news to share for a change.
On 12/12, I had a CT scan, as required by the drug trial at 6 weeks. At that point, I had completed two infusions of the MEDI and daily doses of the Trametinib. The staff emphasized that there is typically not any reaction at this stage but the CT is required for monitoring during the trial. I was repeatedly encouraged to not get my hopes up.
On 12/15, I had my scheduled meeting with my oncologist and research staff. I also had my planned 3rd infusion of the MEDI. My oncologist shared the results of my CT, as I expected to hear nothing of consequence. To everyone’s surprise, all of the melanoma nodules in my lungs have either remained stable or decreased in size, with no new nodules. For reference, I had at least 12 nodules increase in size between my July to October scans and more new ones were appearing. My oncologist and the research staff were amazed at these results after only two infusions over six weeks. This treatment is typically cumulative and takes time to build up in your system.
Here are some of the more interesting excerpts from my 12/12 CT results:
“MULTIPLE PULMONARY NODULES SCATTERED THROUGHOUT THE LUNGS ARE AGAIN
NOTED AND OVERALL APPEAR MILDLY DECREASED IN SIZE SINCE THE PRIOR
STUDY ON 10/30/14. THE MOST PROMINENT NODULES ON THE RIGHT ARE
LOCATED WITHIN THE POSTERIOR AND MEDIAL BASAL SEGMENT OF THE RIGHT
LOWER LOBE (IMAGE 40 AND 48, SERIES 5) BOTH MEASURING 0.7 CM,
DECREASED FROM 1.1 AND 1.0 CM PREVIOUSLY. THE LARGEST ON THE LEFT
MEASURES UP TO 1.2 X 0.7 CM (IMAGE 50, SERIES 5), COMPARED TO 1.7 X
1.1 CM PREVIOUSLY. ADDITIONAL SMALLER NODULES ARE ALSO SLIGHTLY
DECREASED IN SIZE. NO NEW OR ENLARGING PULMONARY NODULES OR MASSES.”
And the summary notes:
“IMPRESSION- FINDINGS CONSISTENT WITH A MILD POSITIVE RESPONSE TO THERAPY.
1. MULTIPLE PULMONARY NODULES ARE MILDLY DECREASED IN SIZE WHEN
COMPARED TO THE PRIOR STUDY, CONSISTENT WITH A POSITIVE RESPONSE TO
THERAPY. NO NEW OR ENLARGING PULMONARY NODULES OR MASSES ARE NOTED.
2. INTERVAL DECREASE IN SIZE OF 0.7 CM RIGHT PERIHILAR LYMPH NODE,
PREVIOUSLY 1.3 CM AND SUV MAX 6.3 ON PRIOR PET/CT 10/11/14.
3. STABLE SCARRING OF THE ANTERIOR RIGHT THIGH RELATED TO PREVIOUS
LYMPHADENECTOMY. STABLE ANTERIOR RIGHT THIGH SUBCUTANEOUS NODULARITY
AND STRANDING UNCHANGED SINCE PRIOR PET/CT 10/1/14.
Although I have a long road ahead of me, it is nice to get some positive news for a change. It is nice to see some positive results, which makes the bad parts of all of this more tolerable. It is just one day at a time for me, but it is always nice when that day is in a good direction.
The rash, which I think is from the Trametinib, got worse for a while. I feel like a 15-year old boy, going through puberty, and wishing I had more Clearasil. Then it got a little better with some ointments and now it is flaring up again. I suspect that the meds force the impurities out of your body. I also suspect that it makes me very sensitive to sun. Even very quick periods from the car to a building seems to cause my face to get flush.
Other issues are mild. Sometimes constipation, sometimes the opposite. Some stomach pains when you first take the Trametinib, which I believe is the cause of most of the side effects. Otherwise, life goes on.
Thanks for listening. I am sending my best to everyone out there who is going through your own personal journey. I hope you find some happiness and solace with your family and friends during the holidays. That is what this is all about. Family and friends. Making it one more day and enjoying that day to its fullest.
MatthewDecember 17, 2014 at 11:12 am #email@example.comParticipant
Hi Matt: So happy to hear about your great news…that is terrific…it is so encouraging. My husband has just finished his 4th infusion of ipi and another drug but not a PD1 or PDL so that will be next up if ipi fails. So glad to hear about positive results from your therapy! Enjoy the holiday season – you are absolutely correct about the support of friends and family…could not do all of this without them.December 17, 2014 at 2:19 pm #65826 I am excited about this trial Mathew and thanks for the post. I just matched someone else with it yesterday and saw it was still recruiting. PDL is especially intriguing and according to our scientific folks a promising molecule. Thanks for continuing to share with us!!March 12, 2015 at 9:24 pm #65827 Hi Everyone. Sorry it has been a while since my last post. It has been a challenging month for me and my family. Mentally, physically, everything. But we are moving forward, as always, and doing our best to remain positive.
I am going to be really hesitant to post any positive updates on this site as it seems to be my personal jinx for a shift in the other direction. As I do not believe in fate, you will continue to get my positive and negative updates. Right after I posted about my 1-year NED, I get a reoccurrence. Right after I post about a good scan, some bad news comes. Melanoma is a cruel mistress.
As per my previous posts, I have been participating in the MEDI-4736 trial since early November 2014. As part of the trial, I am required to get a CT every 6 weeks. My first scan in Dec was very good. Actually, super great. Huge significant reductions in tumor sizes. We were so happy with these results.
On Feb 5th, I had the 2nd scan which was good too. Two of the nine nodules being tracked in my lungs were slightly smaller. The other seven which are being tracked did not increase in size at all. No new nodules have formed. In the wonderful world of melanoma, this is a positive report. I was happy.
On Feb 9th, I had my next schedule infusion of MEDI. Same old same. Just like the previous infusions that I have received since early November. This is old hat to me now, right? Going to be another easy day. One hour infusion, then three hours of monitoring to make sure all is OK, as per the trial protocols. Why do I need to be monitored for three hours anyway? I have never had a problem yet. Regardless, they take my blood pressure every 15 minutes like normal. I am normally about 120/80. During my infusion, my blood pressure rises slightly, as it does with every infusion, to 130/90. No big deal. By the time the infusion is done, it is up to 140/100. Not a major deal but the nurses are paying attention to me now. I can see that discussions are happening about me and phone calls made. And the more they pay attention, the more nervous I am getting. And it just keeps rising and creeping higher. My highest reading was 170/110. They had the doctor come in and approve a quick injection of something to bring down my blood pressure, which happened pretty quickly.
OK. Crisis averted. I was sent home that night but had monitor my blood pressure at home every couple hours. And I had to come back in two days (rather than in two weeks) for a checkup. I was told to stop taking the daily dose of 1.5mg of Trametinib and given some blood pressure medication.
On Feb 11th, my blood pressure was still higher than normal at about 130/95. Also, my TSH and creatinine levels were very high, which was showing that my thyroid and kidneys were not working properly. I was then given some additional daily meds:
– Levothyroxine for my thyroid
– Hydrochlorothiazide for my kidney (diuretic)
– Metoprolol to lower my blood pressure
On Feb 23rd, the oncologist thought it was better to skip the MEDI infusion. Although my numbers all looked good, he wanted to observe everything for another two weeks. It seems to be working. My creatine and TSH have significantly reduced to normal levels. My blood pressure has stayed at 120/80 now.
On March 9th, after one month off both MEDI and Trametinib, I was given another infusion of the MEDI but not restarted on the Trametinib. If all goes well during the next two weeks, they plan to restart me back on the Trametinib at a lower dose, probably 1.0 mg.
As the doctors say, that is part of what they are trying to learn with the trial. What is the treatment plan? How many doses are needed? How often? What is the dosage size? All of that, I guess.
Overall, I feel good. I have very little physical side effects. Since going off the Trametinib, the rash on my face and back have almost disappeared. My blood pressure is still a little high but we are managing that with medication.
I will continue to post updates. I hope this helps someone out there. The journey continues.
MatthewMarch 12, 2015 at 10:59 pm #65828
Good to hear from you! Sounds like full speed ahead again and you are correct, they are still trying to figure out correct dosage and we all know we are different from each other, so it can be very individual. Your good spirits continue and I’m so happy you’ve share this with us. I know what you mean about jinxing yourself! But keep posting, we love to hear from you as you are making history right?March 13, 2015 at 9:01 pm #65829buffcodyParticipant Matthew,
I’m glad things are coming back to normal and you are getting back on course, even a little justifiable optimistic. As you know, I have no particular medical expertise, just my own experience. And your doctor does have expertise obviously. But I am a little surprised at the “uproar” over the high blood pressure readings. I write that because for unknown reasons, not “white coat syndrome” my readings are very labile. They have ranged in recent years from 95/58 to 230/115. I take my blood pressure on a regular basis at home. Most diastolic readings are below 80. Most systolic between 115-130. Same in my primary care’s office where the nurse uses a cuff reading in the “old way” that blood pressure readings used to be done. However, when I am measured using a newer electronic upright machine my blood pressure can be significantly higher. My brain sugeon’s nurse told me she finds the machines to be frequently inaccurate in terms of giving higher readings, which has been my experience. In the surgeon’s office with the machines my pressure comes in at 170 plus over 90 plus. With the arm cuff hand-taken, the pressure is 130 over 80 or less most of the time. Big difference! One of the hypotheses is that the cuffs on the machines are too tight which raises blood pressure. I don’t know about that, but, if I have “white coat syndrome,” it’s not the coats that set it off but, in my opinion, the way the machines operate, sound, press, and start over again when they can’t read your pressure because it is too high. Talk about a set up for raising it even higher. I do take medication for hypertension, which probably makes my condition different from yours. But I was told by an expert in the field to avoid taking my own blood pressure when I think it is high and to realize that one can have high blood pressure for many hours without it doing any damage.
Once again, doing nothing more than sharing my own situation for what it’s worth to you or anyone else.
FrankMay 14, 2015 at 7:35 pm #65830
I hope this post finds everyone in good spirits with positive thoughts. It has been almost two months since my last post. After the excitement from Feb and March, I needed some time to process all of the information and develop the right plan for me and my family. I am very grateful to those who reached out to check on me. I apologize if I caused any needless worry. I just needed some time to focus on my health, family, and personal stuff.
Update: Since April 6th, I have been back on the full course of the combo therapy with infusions of MEDI every 14 days and daily doses of 1mg of Trametinib. The Trametinib is clearly the cause of the few side effects that I have. The most significant is a rash on my face, shoulders, and chest which I have been trying to counteract with a variety of creams including Erythromycin, Hydrocortizone, Clearasil, and Neosporin. None of it cures the rash but it occasionally keeps it at bay. And more importantly, it seems to make me feel better that I am trying to do something to fight it off. While a severe case of adult acne is not the worst thing in the world, it can put your ego into check pretty quickly and keep things interesting. The other side effect seems to be the occasional bout of fatigue but nothing too excessive to keep me from maintaining a relatively-normal lifestyle.
As for meds, I am still on the same daily course of meds for blood pressure, thyroid, kidney, and liver functions. Biggest side effect of this is frequent urination. I am unsure if these meds are my new normal or if they will eventually be eliminated. As for now, my blood pressure, TSH, and creatinine levels have returned to normal levels. Also, since my last post, my LDH, T3, and T4 indicators have steadily reduced and are within normal parameters. Some people say that these latter marker levels are an indicator for disease progression while others say no. Who really knows anything, right? What I do know is that the big pharma companies who are paying for this trial are tracking these markers so it must have some significance. Regardless, it seems like everything is back to normal for me.
Scans: I had a CT on April 1st (yes, fool!
😆) which was not great but I had been off the meds for a several weeks. Slight increases in a couple nodules in my lungs but no new nodules formed. I had another scan on May 1st which was good. Reductions in size in several locations. No new nodules forming. Everyone was happy to see the results. I am planned for another scan during the 2nd week in June. Hopefully, we will see more good results to validate that the combo drugs are working.
What’s next? That is the big question. The docs and researchers are now watching to see what happens. Can my body stay healthy enough, for long enough, for this combo to gradually kill off the nodules in my lungs? Or will my body keep shutting down at the 3-4 month point before the disease can be eliminated for a durable cure?
During the last rounds of combo treatment, it took about four months for everything to go haywire. It has been two months since I restarted the MEDI and one month since I restarted the Trametinib at a reduced dose of 1mg rather than 2mg. As you can imagine, while I am trying to move on with life in general, I am keenly aware of every nuance of my daily health.
So that’s it for me today. I hope everyone is doing their best to stay positive and keep fighting. It is so difficult sometimes to remain the vigilant soldier but we must continue. I send my best wishes to everyone out there, whether you are the soldier or the family member. Both fights are difficult.
MattMay 18, 2015 at 12:52 pm #65831
Thanks for the update! You are very knowledgeable about this trial and that helps many others! I am excited to learn more about the PDL therapies as they offer still another alternative choice for our melanoma patients. I’m sure it was the MEK that probably caused your difficulties, they tend to have more side effects than do the PDL/PD1 for the most part. Are you PDL positive? Did they test for that?June 3, 2015 at 5:06 pm #65832 Just a quick update with very little to add. However, I am trying to keep my documentation comprehensive.
Because of the previous scan results after temporarily stopping the drug combo, my doctor ordered another scan after 4 weeks. However, the pharma company who runs this study still requires scans every 8 weeks so I had another CT scan on Friday, May 29th. The results were overall stable. Two nodules increased by 0.1cm, each. One nodule decreased by 0.1cm. The other five nodule locations in my lungs remained exactly the same size. Thyroid unremarkable. No new nodules.
The journey continues. In this world of my new normal, stable is considered good.June 3, 2015 at 10:29 pm #65833
Stable is manageable and that’s a positive thing. I hope things continue for you in a good way. I have always had a good feeling about PDL but it has lagged in trials and approval. Thanks for lighting the way on this!
- The forum ‘Melanoma Diagnosis: Stage IV’ is closed to new topics and replies.