Tuesday, September 16, 2014

It's a new dawn, it's a new day, it's a new life, and I'm feeling good....

It takes a special person to make a change, to push forward, to persevere when things are less than fun.  For all my besties...feeling better, working hard, moving forward, living it all...the good and the bad....a day at a time...without a magic wand....Jonathan, David, Fred-o, Roo, Jeanne, Frank, Ruthie, Char and Shane.  It's not easy.  But...Nina knows....

Nina Simone - Feeling Good - Bassnectar Remix

Birds flying high, you know how I feel.
Sun in the sky, you know how I feel.
Breeze driftin' on by, you know how I feel.
It's a new dawn, It's a new day, It's a new life, For me
And I'm feeling good, yeah.

Fish in the sea, you know how I feel.
River running free, you know how I feel.
Blossom on the tree, you know how I feel.

Dragonfly out in the sun, you know what I mean,
don't you know?
Butterflies all havin' fun, you know what I mean:

Sleep in peace when day is done,
Stars, when you shine.. you know how I feel.
Scent of the pine, you know how I feel.
Oh freedom is mine
And I know how I feel.
It's a new dawn, It's a new day, It's a new life, For me
And I'm feeling good.

Y'all got this.  It's a new dawn, It's a new day, It's a new life.....for all of you....and that makes me....feel good.  Love - c

Sunday, September 14, 2014

Our lives are not our own...

....From womb to tomb, we are bound to others.  Past and present.  And by each crime and every kindness, we birth our future.

My life extends far beyond the limitations of me.

Thanks, Cloud Atlas....again.  C

Wednesday, September 10, 2014

Anti-KIR (lirilumab) with Nivo - New Trial!!!

A phase I dose escalation and cohort expansion study of lirilumab (anti-KIR, BMS-986015) in combination with Nivolumab (anti-PD-1, BMS-936558, ONO-4538) in advanced solid tumors.

Abstract from ASCO 2014 - Segal, Hodi, Sanborn, Wolchok, Topalian, et al.

Killer cell immunoglubulin-like receptor (KIR) and programmed death-1 (PD-1) are immune receptors that down regulate natural killer (NK) cells and T-cell activity.  Immune checkpoint blockade is emerging as a novel form of cancer immunotherapy.  Lirilumab, an anti-KIR antibody, potentiates NK actitivity and innate immunity, with only modest side effects per a phase I monotherapy trial.  Nivo, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, potentiates T-cell activity and adaptive immunity, and has shown durable activity in various solid tumors, including melanoma, kidney cancer and non-small cell lung cancer.  We hypothesize that [together...they will result] in greater clinical activity than with either agent alone.

This is the first collaborative trial to be conducted by the International Immuno-Oncology Network.  150 patients with any solid tumor (excluding primary central nervous system tumors) will be given Nivo at 3mg/kg IV q2wks plus lirilumab 0.1, 0.3, 1, or 3mg/kg q4wks, in 8 week cycles (max 12).  Primary objectives are to determine safety, tolerability, dose limiting toxicities, and max tolerated dose of the combo.  Secondary objectives = anti-tumor activity, drug action, and immunogenicity, as well as effects on tumor infiltrating lymphocyte subsets in melanoma and squamous cell carcinoma patients.  Exploratory objectives include assessment of innate and adaptive immune responses in peripheral blood and/or tumor specimens and correlation with clinical outcomes.

Trial info -NCT01714739

Still recruiting as of August update!! Locations in the US = University of Chicago - IL, John Hopkins - Maryland, Dana-Farber - Mass, Sloan Kettering - NY, Providence Portland - Oregon.

Wishing my best to all the ratties!!! - c

Sunday, September 7, 2014

Studies listed as adjuvants for melanoma (including uveal, mucosal and ocular)....not advocating all of them, but adjuvant options are out there...forgive formatting, best I could do! Call the sites if interested!!!



Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients   NCT00553618 For-Metastatic Melanoma, Drug = Proleukin, Dacarbazine

NCT02223819 For-uveal melanoma, Drug = crizotinib


Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal NCT01341496 For-sarcoma, melanoma epithelial and pleural malignancies.  Drug = Modifies autologous tumor, cyclophosphamide, celecoxib

Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients NCT01729663 For-cutaneous mel, Biological-CSF470 vaccine, BCG, molgramostim, Drug-interferon alpha 2b

Not yet recruiting

Not yet recruiting
NCT02068586, For-ciliary body and choroid melanoma and intraocular mel,Drug-Sunitinib, valproic acid


Ipilimumab for Uveal Melanoma NCT01585194, For-uveal mel, Drug, ipi


NCT01543464, For-malignant mel, Drug = chemo-temozolomide

For-recurrent mel, Stages 111B, IIIC, and IV.  Drug = ipi, recombinant interferon

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists NCT02126579, For-mel – metastatic and mucosal.  Drug = peptide vaccine LPV7+tetanus peptide, polyICLC, Resiquimod

For-uveal mel, monosomy 3 positive, no mets.  Drug = autologous dendritic cells

NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma NCT01810016 For-unresectable mel.  Drug = ipi, NY-ESO-1protein vaccine, NY-ESO-1OLP4 vaccine

NCT01970358 For-mel, Drug = poly-ICLC peptides

Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma NCT02094391 For-in-transit mel Stage IIIB and IIIC. Drug = ipi


{NOTE – my trial….peptide vaccines no longer given}


NCT01308294. For-mel, Drug = vaccine



CDX-1401 and Poly-ICLC Vaccine Therapy With or Without CDX-301in Treating Patients With Stage IIB-IV Melanoma NCT02129075 For-ciliary body, choroid, extraocular, iris, intraocular, mucosal mel or melanoma Stage IIB – IV Drug = recombinant flt3 ligand, vaccine

NCT01838200 For-metastatic mel, Drug = BCG vaccine, ipi

Vaccine Therapy With or Without Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma NCT01307618 For-recurrent mel, stageIV.  Drug = peptide vaccine, MAGE-3.1 antigen, interleukin-12, Mart-1 antigen

Trial of pIL-12 Electroporation Malignant Melanoma NCT01502293 For-mel, Drug=Plasmid interleukin-12


Thursday, September 4, 2014

Merck's anti-PD1 drug gets FDA approval!!!

It's true.  FDA approval granted to Merck's anti-PD1 drug - MK-3475/Pembrolizumab...now to be marketed as Keytruda.  Here's a link from TheStreet, The Wall Street Journal, and OncLive:

MK3475/Pembrolizumab/Keytruda is FDA approved

fda-approves-mercks-cancer-drug- article by Peter Loftis of Wall Street Journal

FDA-Approves-Pembrolizumab-for-Advanced-Melanoma - OncLive

The gist:  A Merck spokesperson reports that Keytruda will cost $12,500.00 per month - $150,000.00 for a year of treatment.  "It was approved for people who've failed to respond adequately to Yervoy (ipi)."  Failure of a BRAF inhibitor in BRAF positive patients will be required as well.  The BMS anti-PD1 product, Nivolumab, was approved in Japan under the name of Opdivo earlier this year.  BMS is expected to file by September 30 for FDA approval of Nivo as a treatment for melanoma and to file by year's end for its approval as a treatment for lung cancer here in the United States.

Dosage per package insert:  2mg/kg infused every three weeks until disease progression or unacceptable toxicity.

Scuttlebutt, so I'm not sure of the total accuracy here:  EAP centers will close and transition to commercial insurance with a transition team. If unable to pay, there will be assistance through: http://www.merckaccessprogram/keytruda.com

Clearly, a very good start for many folks.  I am disappointed about the requirement to have failed ipi and BRAFi, for the BRAF positive, beforehand and fear the cost of treatment will become a barrier for many.  But, a big step in the right direction!!!

Here's to all the ratties who made it happen!!! - c

The ALS ice bucket challenge, Think Pink, and Melanoma...closer to free!!!!

     Unless you've been living under a rock, you've heard of the ALS (Amyotrophic Lateral Sclerosis) ice bucket challenge to benefit the ALS Association - working to raise awareness, education and research for Lou Gehrig's Disease.  Think "Tuesdays with Morrie."  ALS is a disease that currently has no treatment other than supportive care for a slow and certain decline with gradual loss of muscle function causing cessation of movement and ability for self care, to lack of speech and respiration.  Surely one of the cruelest diseases out there in a sea of many nasty ones.  At any rate, the ice bucket challenge, in which participants dump a bucket of ice water over their heads via a video posted on various social media outlets, make a donation, and challenge friends to do the same, has become a cultural phenom embraced by celebrities and regular folks alike.  I fear many have used the ploy to simply have something cool to post on Face Book without offering up the donation, but plenty have given and given big! The ALS Association reports that they have acquired more than 94 million dollars this past August, compared to only 3 million in August of the prior year.  The president and CEO has vowed to look at the amazing windfall carefully and find ways to make it really work for those suffering.  Charity Navigator, an organization that evaluates charities, has given the ALS Association a rating of 4 out of 4 stars with specific kudos for accountability and transparency, and report that 72.4% of donated dollars go directly to research and education.

     Then there's ~ PINK!  The pink ribbon, symbol for breast cancer awareness, began with the Susan G Komen Foundation in the fall of 1991, as a derivative of the red ribbon campaign for AID's awareness that was having success at that time.  Because the pink ribbon and pink product packaging has become so ubiquitous and has been put to questionable use by companies and business seeking to promote their products without the avowed support to breast cancer programs and agencies, criticism and organizations like "Think before you Pink" have developed.  Such organizations encourage shoppers to check to see how much of the "pink" companies' proceeds really go to breast cancer programs, how that program uses those funds, and to find out if the company has actually "capped" the funds they will donate.  There is a huckster in every crowd, but overall, no one can deny the good the PINK campaign has done to raise breast cancer awareness, take away the stigma, find new and better treatments, minimize suffering, and offer real options to patients that can often result in cures!!!

     So....what has all this to do with melanoma?  Sadly, jealousy over PINK has been a long simmering ugliness that occasionally rears its head on various melanoma forums and discussion boards.  "We deserve the kind of funding and attention that PINK for breast cancer does!"  "Why don't we have PINK?"  When I was first exposed to this kind of thinking, I was shocked!  Wow!  You really begrudge folks getting help for a horrible disease process just cause you have a horrible disease yourself????  It is not an attitude of the majority by any means.  And, I'm sure some just mean that they wish things were better for melanoma suffers rather than the broader desire that some are very clear about ~ "Melanoma is worse and we deserve the money/help/cure/research more than THEY do!"  Anyhow, I learned to tune it out...pretend it was not there.  But....here we go again.  Probably the same bitter folks....I haven't bothered to research it....have been irritated to the point of turning into a big green goose of fury over the success the ice bucket challenge has brought ALS.  Seriously people.  There is more than enough misery to go around.  More than enough smarts and money to help everyone, too....if we just would.

    All of this to explain why I was so heartened to see this posted by Cathy Baker....and I have her permission to share it with you:
And this????  This is just awesome!!!

Closer to Free...ALL cancer survivors FLASH MOB celebration

Isn't that the truth? We've all got more than enough troubles  Let's focus on the good!!! - c

Monday, September 1, 2014

Anti-PD1 after ipi.....

Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomized dose-comparison cohort of a phase 1 trial

Robert, Ribas, Wolchok, Hodi, Hamid, Kefford, Weber, et al.  The Lancet. July 15, 2014

Pembro at 2mg/kg and 10mg/kg every three weeks were compared in 173 patients who had progressed after at least two ipi doses.  They were randomly assigned to the dose sets. Median follow-up was 8 months.  Overall response rate was 26% at both doses.  Treatment was fairly well tolerated  with similar safety profiles in both dosage groups.  Most common side effects were fatigue, rashes, and itching.  "Results suggest that pembrolizumab...might be an effective treatment in patients for whom there are few effective treatment options."

These results are consistent with what we are learning from other studies.  Ipi naive patients have a better response rate to anti-PD1, but some folks can still attain positive responses to anti-PD1 even when they have progressed on ipi.

Infomation presented at ASCO included these overall response data:

Pembro every three weeks in ipi naive patients = 40% overall response rate
Pembro every three weeks in ipi refractory patients = 28% overall response
Nivo in ipi naive patients = 41% overall response rate.

For more details you can check the post below:
Earlier post with info from ASCO comparing - nivoipi-combo-nivo-vs-pembro-pd-l1

Best - c