MPIP: Melanoma Patients Information Page

The MPIP is the oldest and largest community of people affected by melanoma hosted through the Melanoma Research Foundation. It is designed to provide support and information to caregivers, patients, family and friends. Once you have been touched by melanoma—either as a patient or as a family member or friend of a patient—you become part of a community. It is not a community anyone joins willingly. But if you must be part of this group, you will find no better place to find the tools you need in your journey with this cancer, and the friends who can make that journey more bearable.

The information on the bulletin board is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

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lou2's picture
Replies 1
Last reply 4/14/2013 - 10:00pm
Replies by: mbaelaporte
News February 01, 2013
 

Implementing Health Reform: Boosting clinical trial participation

 

IMNG Medical Media, 2013 Feb 01, ME Schneider

Following the lead of Medicare and several states, the Affordable Care Act guarantees insurance coverage for individuals participating in clinical trials for the treatment of cancer and other life-threatening diseases.

Under the 2010 health law, health plans offering individual or group coverage cannot bar participation in clinical trials and cannot discriminate against patients who take part in trials. Health plans must cover the routine patient costs associated with participation in certain clinical trials. The plans do not, however, need to cover the investigational drug or device or services provided solely to satisfy data collection and analysis needs.

The policy applies to all phase I-IV clinical trials that are conducted for the prevention, detection, or treatment of cancer or other life-threatening diseases, including federally funded trials, investigational new drug applications reviewed by the Food and Drug Administration, or drug trials that are exempt from having an investigational new drug application.

The new federal policy, which takes effect on Jan. 1, 2014, sets a minimum standard of coverage and permits more expansive state coverage laws to continue.

Dr. Sandra M. Swain, president of the American Society of Clinical Oncology (ASCO), is an expert in the field of inflammatory breast cancer treatment and has led more than 20 clinical trials. She explained how the policy change is likely to impact clinical trial participation.

 

Question: How many states already mandate coverage of clinical trials and do the laws vary?

Dr. Swain: Twenty-nine states and the District of Columbia have laws and six states have voluntary agreements with insurers to provide coverage. The laws vary tremendously. The laws and agreements do not cover plans for self-insured, large-employer plans (or so-called ERISA plans) because they are regulated by federal, not state law.

 

Question: Will this new federal policy follow Medicare’s example and covering the treatment of complications in clinical trials?

Dr. Swain: The ACA statute does not specifically mention coverage of complications. ASCO led a coalition of 19 cancer organizations in advocating for the Centers for Medicare and Medicaid Services (CMS) – the federal agency in charge of drafting the implementing regulations – to require in those regulations that insurers cover complications. The coalition submitted proposed regulatory language on this and a number of other issues and met with CMS. We are waiting on the draft regulations.

 

Question: Is the current lack of insurance coverage for clinical trials a significant barrier to participation?

Dr. Swain: Our members have cited this as a major concern. Health plans do not always deny coverage, but they often don’t make coverage explicit and there is a lot of paperwork and time delays. This can make it difficult for patients to enroll in trials in a timely manner. Some patients also choose not to consider trial participation when they learn that their health plan may not provide coverage. An analysis from Johns Hopkins University, Baltimore, provides the most recent data.

 

Question: Since this doesn’t apply to grandfathered health plans, how much of an impact is it likely to have?

Dr. Swain: When the Office of Management and Budget released a rule on grandfathered plans in June 2010, it also estimated how many plans would relinquish their grandfathered status by 2013. The conservative estimate is 39% while the high-end estimate is 69%. As time goes on, the number of plans that lose their status will increase, thereby also increasing the effect of the provision.

 

Question: What will the impact be on cancer research and patients?

Dr. Swain: We’re hoping it will help make it easier to participate in clinical trials. Perhaps our outreach to ASCO members and patients about the provision will increase awareness. Anything that makes it easier to participate in research will ultimately help bring new treatments to our patients.

 

Question: What will need to be addressed when the Department of Health and Human Services issues regulations on this provision?

Dr. Swain: The statutory language about which trials are covered is very clear. Federally funded trials (including those funded by Cooperative Groups and National Cancer Institute–designated oncology centers) for the prevention, detection, or treatment of cancer are covered – including all phases of trials (I-IV). In addition, these same types of trials that are privately sponsored are covered if they are regulated by the FDA under an investigational new drug (INDA) application or if they meet requirements to be INDA exempt. We are working with the federal government to make the coverage process as timely and straightforward as possible. We developed a standard form that could be sent to any insurer to confirm that a trial meets the coverage requirements. We are hopeful that the federal government will promote use of this type of streamlined process. It is crucial that we help patients obtain a clear coverage answer as quickly as possible.

 

Dr. Swain is the president of ASCO and the medical director of the Washington Cancer Institute at the MedStar Washington Hospital Center.

 

------------------------------------------------------------------------------------------------------------------------------------------------

 

And just in case you thought this was going to be easy to understand, here is more on grandfathered health plans:

http://www.healthreform.gov/about/grandfathering.html

 

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rbruce's picture
Replies 28
Last reply 4/14/2013 - 9:45pm

After over a year of nothing but bad news and constant tumor progression, I just met with my Doctor at UCSF who was excited to tell me that I have had over a 30% tumor reduction from the ANTI-PD1 trial I am on.  All of the results out of ASCO last weekend in Chicago about ANTI-PD1 have been very promising and have shown that responders continue to respond.  I am so grateful for the groundbreaking research that is bringing these new immunotherapies to the forefront. I am so thankful for my friends and family that have supported me.  I am eternally thankful to my love, my partner, Lisa who, without her constant love and positive encouragement, I would be lost.  

 
Today is a happy, happy day.  I thank God he continues to give me more time to live each day to the fullest.  I ask for God's blessings in your lives.
 
With love and gratitude,
 
Robert

The circumstances of our lives have as much power as we choose to give them. David McNally

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I love to ride my bike and hike...again. I cover myself, put on SP 70, but come back sunburned in the face, and my nose skin peels like a snake. What gives? I do live at almost 7,000 feet in Colorado with more UVs, but still this didn't happen before to this extent.

The history of the world is the battle between superstition and intelligence.

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arborbnb's picture
Replies 8
Last reply 4/14/2013 - 8:17pm

I don't come to MPIP very often but back 12 years ago it was my lifeline .... I was julieincanada.  I just wanted to let you know that my husband Peter turned 65 in February - we were in Hawaii and met Vicki for the first time!  Peter was dx with Stage 3b in August of 2001.  He had several surgeries, a year of high dose IFN and 6 weeks radiation.  Yes, it was very difficult and the side effects were paralyzing.  He was off work for 7 years and we really didn't think the IFN fog would ever go .  Well it did!  He is getting ready to start another year of working in mining construction .  He flies to work in a helicopter and has learned about a whole new industry.  Life is very exciting for him.  Yes he still needs gaba for neuropathy but his life ( and mine) are good.

 

Don't give up! miracles happen.  One day at a time.

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Kelly7's picture
Replies 13
Last reply 4/14/2013 - 7:00pm

Hello,

 

My brother just had his first dose of Yervoy on Wednesday and so far he feels good. I have read many posts and it seems like most people that have symptoms between dose 2 and 3. I asked my brother to ask his doctor what to look for, but his doctor told him that only 7% of people have symptoms. I feel like that number is low from reading the posts on this website. I also feel his doctor has down played treatments before(IL2). I just want my brother to be vigilant in looking for symptoms. His doctor told him that if he gets diarrhea to take imodium ad . But I'm pretty sure I read on this forum that that is a ridiculous treatment. 

 

The hospital that he is receiving Yervoy is about an hour away, so if there was any emergency he would have to go to a local hospital. I just want them to be informed and my brother as well. He is not as keen as I am to join in and participate in these type of forums. He seems to just take whatever the doctor says as 100%.

 

Thank you for any advise!

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Bunmom's picture
Replies 4
Last reply 4/14/2013 - 1:15pm
Replies by: vivian, akls, DebbieH, Linny

I'm 8 days post-op and my JP Drain is still draining quite a bit--more than 100 ml/day. I have an appointment Monday and thought I'd get it out then but now I'm thinking I won't. If you had this surgery, how long did you have the drain? 

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LynnLuc's picture
Replies 9
Last reply 4/14/2013 - 3:15am

Today is my 3 year NED ( No Evidence of Disease ) Anniversary with Stage 4 Melanoma!e 4 melanoma!- Lynn

Advocate for your own treatment.. Stage 4 Melanoma NED Surgery,Radiation, Temodar 300Mg July 2009-March 2010, then Thorocotomy...now "Phase I Study of Anti-PD-1 Human Monoclonal Antibody MDX-1106 and Vaccine Therapy"

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Richard_K's picture
Replies 8
Last reply 4/13/2013 - 6:51pm

 

I had a weird appointment with my doctor today, weird because this was the first appointment where there were no scans to review.  The scan frequency was recently changed to every twelve weeks from every six.

I was anxious about my blood work though, specifically my bilirubin.  Not to worry, all was fine and I got enough Zelboraf given to me for another six weeks.  It’s now a little over 37 months on Zelboraf.

Dick

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tony9511's picture
Replies 10
Last reply 4/13/2013 - 3:35pm

Really enjoy reading some of the posts on this board.  Once I have completed the procedure and am able to get back on this site I will be asking for different experiences with the aftercare.  Radiation, Interferon etc etc.  My surgeon says there will be a variety of options available, so that is a good thing.  But than again its the VA and you never know.  Good Luck everybody in their fight against this pain in the......disease. 

Tony

May 2012 stage 2 Clarke level IV...wx surgery

March 2013 reoccurrence same spot on should wx surgery......positive neck lymph nodes, armpit lymph nodes

April 2013 neck surgery.

May  2013 the real fight begins.

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Anonymous's picture
Anonymous
Replies 3
Last reply 4/13/2013 - 2:47pm
Replies by: washoegal, mark1101, Anonymous

Articles from journal.  Puzzled that they are describing interferon in this way.  Don't I understand that interferon is not a great success in melanoma? Perhaps I got this wrong?

___________________________________________________________________________________________________________________

 

Interferons and Their Antitumor Properties

Leonidas C. Platanias
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
143-144.
http://online.liebertpub.com/doi/abs/10.1089/jir.2013.0019?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Biological Rationale and Clinical Use of Interferon in the Classical
BCR-ABL-Negative Myeloproliferative Neoplasms

Brady L. Stein and Ramon V. Tiu
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
145-153.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0120?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Immunomodulatory Effects of Interferons in Malignancies

Joseph Bekisz, Yuki Sato, Chase Johnson, Syed R. Husain, Raj K. Puri,
and Kathryn C. Zoon
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
154-161.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0167?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Interferons as Inducers of Apoptosis in Malignant Cells

Kevin P. Kotredes and Ana M. Gamero
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
162-170.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0110?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Interferon-γ-Induced Necrosis: An Antitumor Biotherapeutic Perspective

Siddharth Balachandran and Gregory P. Adams
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
171-180.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0087?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
STAT Activation in Malignancies: Roles in Tumor Progression and in the
Generation of Antineoplastic Effects of IFNs

Ben X. Wang, Leonidas C. Platanias, and Eleanor N. Fish
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
181-188.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0154?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Regulation of snoRNAs in Cancer: Close Encounters with Interferon

Shreeram C. Nallar and Dhananjaya V. Kalvakolanu
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
189-198.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0106?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
A Death-Promoting Role for ISG54/IFIT2

Nancy C. Reich
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
199-205.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0159?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
The Schlafen Family of Proteins and Their Regulation by Interferons

Evangelos Mavrommatis, Eleanor N. Fish, and Leonidas C. Platanias
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
206-210.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0133?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

------------------------------------------------------------------------
Hope and Fear for Interferon: The Receptor-Centric Outlook on the
Future of Interferon Therapy

Serge Y. Fuchs
Journal of Interferon & Cytokine Research, Vol. 33, No. 4, April 2013:
211-225.
http://online.liebertpub.com/doi/abs/10.1089/jir.2012.0117?ai=sk&ui=1i85m&af=T#utm_source=ETOC&utm_medium=email&utm_campaign=jir

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Mickey n Jo's picture
Replies 18
Last reply 4/13/2013 - 8:43am

Hi everyone. As I stated in a previous post, my husbands most recent Pet scan suggested multiple tiny brain mets. This was comfirmed by a brain MRI. His melanoma specialist feels that at this time, it would be too debilitating for him to have WBR, she also feels that Yervoy is not an option, since he suffers from gastrointestinal issues ( including a previous bowel perforation). A clinical trial is also off the table since traveling and time commitment would be too much for him right now. His Dr. wants to put him on dabrafenib as soon as it is approved, which she says hopefully will happen within the next two months. For now, he is still taking Zel, 3 and 3, which seems to kind of keeping things in check, but for how long?  I am terrified that things will progress before dabrafenib is approved. We have fought so long and so hard, I just feel like we should be doing something proactive, and not just waiting for it to be approved. So please, anyone with any info on approval time or compassionate use, respond to my post. You have all been a great source of info in the past and I thank you all.

                                                                                                                                      Jo

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natasha's picture
Replies 19
Last reply 4/12/2013 - 7:34pm

Hello dear friends !!

    It is more then an year since my diagnosys of melanoma stage 1a and one year since my WLE.

   I visited hospital every 3 months for the year .

  My scar on the breast is healed perfectly - even unnoticable but yesterday I noticed raised part on the scar , it feels as a a small lump and was a bit blueish..

  I pressed on it several times ,trying to invistigate that it is and blood appears under the skin ,so now it is blood spot still stays under the skin , and this lump is not bluish any more.

 Can it be local reccurence ? Is it possible to have some blood clots in the scar after 1 year???

 I made appointment with local dermotologist but still need to wait to see her.

 I would appricate any advice and opinion.

 Thank you very much !!

 Natasha

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JoshF's picture
Replies 1
Last reply 4/12/2013 - 2:11pm
Replies by: hbecker

Hi All-

Been holding out on this questions but anxiety is getting to me. Just a brief recap about my history so you understand where I'm coming from.

 

April 2011- bump in cheek removed. Path says metastatic melanoma...no leison found anywhere. Find specialist (mel)...thinks maybe primary dermal. Pet scan...negative, re-excision found 5.7mm melanoma in circrumference...depth not measured due to no epidermal component, SNLB negative.

2011-Current. Regular skin exams, eye exams, 1 mucosal exam. CT scans of chest, neck, pelvis abdomen every 3 months...all negative

So last scan in Feb was good but not long after I notice the tinest of bumps towards the roof of my mouth. Figured if was burn scrape etc... Well at 6 weeks now. I had dentist appt about 3 weeks ago and mentioned to him. He did xray and exam. Couldn't really see anything and x ray wasn't concerning though he said xray wouldnt be good to really diagnosis malignacy. He said thought it might be trauma and damage to gland which creates a tiny cyst called a mucceloe (sp?). This thing gets to size of a pin head...they type that has tiny ball on top (maybe not even that big), then it goes down basically to nothing. Actually feels like little piece of skin hanging...like when you burn your mouth eating. Anyway...he saw nothing of concern but given my history he said to see oral surgeon. I did that earlier this week. He said he can see the slight redness (was inflammed from brushing teeth) which was good...but guy was a quack...sais he would take it out then asked me if I wanted to be put to sleep for procedure....really. This thing isn't huge...just scares me and he scared me with that question. So I looked him up and he is on probation for anesthetic related issues and a guy died in his chair. Thank you MRF and all of you have educated me in being diligent about my care. So I'm going next week to see a different oral surgeon. I'm nervous....keep thinking about oral/mucosal melanoma given they never found a primary. Anyone out there have any insight or knowledge, experience with this? Really hoping it's nothing...I'm right at 2 year point and my oncologists feel I'm in good spot but I know this can come back anytime...anywhere....though its typically in first 2 years....which I am at. Hoping someone can respond.

 

Josh

Let's work for better treatments....for a cure!!!!

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Tim--MRF's picture
Replies 4
Last reply 4/12/2013 - 12:28pm
Replies by: mrsmarilyn, POW, Owl, NYKaren

I have been on the road a lot and am a bit behind on posts with MPIP.  Karen, thank you for flagging your post about the new GSK drugs.

GSK has two drugs for melanoma--one is a BRAF inhibitor like Zelboraf (vemurafenib).  The other blocks the next step down in the MAP kinase pathway--MEK.  The data is complete on these drugs and the FDA is currently reviewing the data.  They have announced June 3 as the PDUFA date on these drugs, or the date by which the FDA response to the application will be made.  Sometimes the PDUFA date is pushed back, as happened with Yervoy (ipi) but this is rather unusual.  More likely the June 3 date will hold, or something will be announced early.

The BRAF drug, dabrafenib, will only be available to people whose tumor has the BRAF mutation.  The MEK inhibitor, trametenib, will likely be used for people who are BRAF wild type but have the NRAS mutation, and may be used more broadly than that.

The best thing about this is that with an approved MEK inhibitor doctors can more readily prescribe the BRAF and MEK drugs on combination.  The data is clear that this is a better approach than a BRAF inhibitor alone.

Since GSK did not apply for approval of the combination it is not clear if payers (insurance companies) will cover the cost of the combination.  This will all need to be worked out, and might be an opportunity for the patient voice to be heard.

By the way, I am in Denver for our bi-annual in-person board meeting.  If you have anything you would like me to convey to our board please send me a note at tturnham@melanoma.org.  We meet this afternoon and tomorrow morning.

Tim--MRF

 

 

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Hello-My brother has been battling for over 11 years.  Recently he had two brain mets- in the left and right ventricas.  After spending a month in Mayo Jax, he is at home.  He is on Zel and we are seeing reduction from neck down (4 mets gone).  The two in brain not progressing.  He had 12 rounds of WBR as targeted radiation was not an option - the tumors were bleeding . I also would recommend if anyone has ever had a brain met to get scanned every 30 days- those two popped up in 45 days.

 

Now after his first check up - the Zel or it could be a delayed reaction of Yervoy - or combo of both - no more brain bleed, the brain mets slightly smaller, and as mentioned, body mets reducing.

 

We are going to see Moffitt center late April, but his wife would like to know if he is a candidate for targeted brain radiation after the WBR?  I feel like let the Zel work - and also hold out for the Dabfranib (does anyone know approval date?)

This battle almost took him out, but he is a fighter.  There is reduced mental capacity - but hoping that will improve-they say about 6 months.  I know I have a lot of questions!

You guys have helped us out for a long time- and we appreciate it from the bottoms of our stressed out hearts!!

All the best and thank you again,

MrsMarilyn

(sister of gary Stage Iv)

 

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