Archive | August 2012

Waiting…

Ever think about the word “wait”?

You know the one…the word that is used to teach us to relax and learn to have some patience? Like the prophet Isaiah says “But they that WAIT …. shall renew their strength; they shall mount up with wings as eagles; they shall run, and not be weary; and they shall walk, and not faint” (Isa. 40:31). Yep, that’s the word WAIT.

Does it mean you can curl up in that comfy overstuffed chair and do nothing, expecting something to happen?  I wonder…

I know that in Ecclesiastes 3:1 says that there is a time and a place for everything, so I suppose there is a time for that too.

When I first began this battle with Melanoma I used to pray and  beg  night and day.  I would then find myself “waiting” and “waiting”. I am not a  patient person and my need seemed so simple and immediate-just  heal me! I had no time to “wait”!

One day I was reading Isaiah 40 again and experienced the “Ah Ha” moment! I found that the scriptures weren’t telling me to chill out or to rest on my butt; I was suppose to WAIT on Him…to SERVE HIM as if He were a diner at the Roadside Inn. In helping others  was really serving Him.

I found myself running on empty at times; the needs of others over shadowed my own. Their needs seemed far greater than my own. We shared many of the same problems and were fighting the same battles . I could help them yet I had to WAIT!  Didn’t seem quite fair.

Where and when comest my help????

Many times I asked myself why I get so involved with people when  I can’t even help myself.

Then one day I realized by waiting on others, HE was waiting on me! All the answers and solutions I found for other people were in fact the same answers and solutions I needed for myself!

I am blessed. I am ‘healed’. I am stage 4 with no evidence of disease.  And now that scripture makes oh so much sense when it says they who wait on Him shall renew their strength. They shall mount up with wings as eagles; they shall run, and not be weary; and they shall walk, and not faint.

My Melanoma Experience

I was responding this morning to a fellow Face Book melanoma warrior about the B-raf drug. I didn’t have the opportunity to get into that first trial but it was my first choice when I was diagnosed with stage 4 Metastatic Melanoma. It started me looking across time to 1992 when I was diagnosed with a “precancerous” long dark freckle on my neck called lentigo maligna. They said it was nothing, yet they cut every mole off my body…that’s the Army way, all or nothing! It returned as a very ugly purple eraser in the very same place on my neck less than 4 years later.

I believed the “professionals” again back in 2000 when they said I had nothing to worry about. My path report said “Within the dermis is a tumor composed of sheets of mildly atypical melanocytes some of which are pigmented. The pattern is consistent with malignant melanoma and involves a widened papillary dermis. Unequivocal invasion into the reticular dermis is identified. There are a few atypical melanocytes within the epidermis although pagetoid spread is not a prominent component. Tumor thickness is measured 1.45 mm. Clark’s level 3.  They cut out the 5 sentinel lymph nodes and reassuring me they were all clear.

No one was reassuring in June 2009. I was Stage 4.

I think PLX 4032 (Vemurafenib/Zelboraf) is an awesome drug. It was one drug my hubby and I followed and marveled at when it was still in clinical trials in Australia before it made it to the states. Back in July 2009 I even called Germany and tried to get into the first trials-they pointed me to Roche and Plexxikon in California to get the information on the initial arrival of the first trials.

The criteria required that I needed at least one systemic treatment which failed, along with having the mutation. My first treatment was palliative care…radiation and Temodar…they said I was dying so they wanted to give me a little more time. It was only 4.2 cent at the time but it was pressing against my superior vena cava. Over time it would cut off all my blood supply…They said the radiation and Temodar would keep the melanoma from growing and spreading for 5-7 months, but after that there was nothing more they could do (that was Mayo Clinic in MN). They said that of all the places to get melanoma, it was the worst place possible. (I still don’t understand that…they transplant hearts and lungs…how can this be worse). So medically speaking my treatment didn’t fall into systemic treatment category…that sucked.

That’s when I had to look for a different trial.  Fred Hutchinson Cancer Research Center while little known among society was making headlines in 2008-they were on the cutting edge of immunotherapy.  Headlines read Patient’s own infection-fighting T cells put late-stage melanoma into long-term remission — without chemotherapy or radiation”

Case is first to show safety and effectiveness of using cloned cells alone to kill tumors

SEATTLE — June 18, 2008 — Researchers describe the first successful use of a human patient’s cloned infection-fighting T cells as the sole therapy to put an advanced solid-tumor cancer into long-term remission. A team led by Cassian Yee, M.D., an associate member of the Clinical Research Division at Fred Hutchinson Cancer Research Center, reports these findings in the June 19 issue of the New England Journal of Medicine.

Yee and colleagues removed CD4+ T cells, a type of white blood cell, from a 52-year-old man whose Stage 4 melanoma had spread to a groin lymph node and to a lung. T cells specific to targeting the melanoma were then expanded vastly in the laboratory using modifications to existing methods. The lab-grown cells were then infused into the patient with no additional pre- or post-conditioning therapies, such as growth-factor or cytokine treatment. Two months later, PET and CT scans revealed no tumors. The patient remained disease free two years later, when he was last checked.

“We were surprised by the anti-tumor effect of these CD4 T cells and its duration of response,” Yee said. “For this patient we were successful, but we would need to confirm the effectiveness of therapy in a larger study.”

Yee cautioned that these results, presented in the journal’s “Brief Report” section, represent only one patient with a specific type of immune system whose tumor cells expressed a specific antigen. More studies are needed to confirm the effectiveness of the experimental T-cell therapy. If proven successful in more patients, Yee predicted this therapy could be used for the 25 percent of all late-stage melanoma patients who have the same immune-system type and tumor antigen.

Using a patient’s own immune system to combat cancer, called immunotherapy, is a growing area of research that aims to develop less-toxic cancer treatments than standard chemotherapy and radiation.

The patient in the journal report was one of nine patients with metastatic melanoma who were being treated in a recently completed clinical trial to test dose- escalation of autologous CD4+ T cells. Earlier studies performed by Yee used CD8+ T cells, which do not persist in the body without the support of CD4+ T cells or growth factors such as interleukin 2. Yee and colleagues theorized that infusion of a massive dose of CD4+ T cells would persist longer in the body because they make their own growth factor, interleukin 2, while stimulating the anti-tumor effect of the patient’s existing CD8+ T cells. However, until recently there was no feasible way to isolate and expand anti-tumor CD4+ T cells in the lab.

The researchers were successful in all of these areas. The patient received a dose of 5 billion cloned CD4+ T cells with specificity for the melanoma-associated NY-ESO-1 antigen. The cells persisted for at least 80 days in the patient’s body. And, even though only 50 percent to 75 percent of the patient’s tumor cells expressed the NY-ESO-1 antigen, the entire tumor regressed following the infusion. The scientists postulated that the patient’s immune response was broadened to other antigens expressed by the tumor cells. Follow-up tests showed T-cell responses to two additional tumor antigens, MAGE-3 and MART-1.

I went to Fred Hutchinson Cancer Research Center  in Seattle in February 2010. I believed that if I am going to survive this, it was where I needed to begin. The plan was to take my T cells and clone them over 4 months…they were able to gets gazillions of them to grow…the trial was called “Phase I/II Pilot Study of Cellular Adoptive Immunotherapy With Autologous CD8+ Antigen-Specific T-Cell Clones in Combination With Low-Dose Aldesleukin and Denileukin Diftitox in Patients With Metastatic Melanoma”.

While my clones were procreating, I was to go back home and wait. I could continue to do the Temodar and then when my cells were ready I would stop and wait until my counts were normal…then go back to Seattle. I arrived home and had a PET scan appointment the same week. My SUV had been sitting at 4.3 since I had radiation and starting Temodar back in July 2009. It was ‘stable’…BUT this PET report said…it jumped to “over 7”. Now Fred needed 4 months to clone my cells and Mayo told me nothing more could be done…so I did more research.

 

I went back to Mayo. My oncologist said they knew the Temodar would stop working and reminded me that they told me in the beginning that it would only be a temporary fix.

 

All I could think of was to have surgery and cut this thing out. I couldn’t wait 4 months for my clone army to develop!

 

My Mayo surgeon previous refused to do surgery- due to the location ( it was by my heart, at the top of my lungs where all the arteries, veins and vessels come together)-He said no way..He said unless it regressed down to the size of a bb he wouldn’t touch it. I didn’t care what he said- I wanted surgery and this Irish/German woman never took No as a final answer. My mom always said I was stubborn and I wouldn’t listen- she was right.

 

The melanoma was now 6.8 cent and growing, cutting off my blood supply to the top half of my body. What did I have to lose? Just like they said-I was dying.

 

I found a surgical report on line that had been done some 20-30 years before with some success by a surgeon back east who did some mediastinum surgery. They removed a cancer and the patient lived through surgery. That’s all I wanted. I would figure out what to do next after surgery, but for now I wanted to have a fighting chance.

 

I expected Mayo to either do it or refer me to someone else who would do it. I printed out my research paperwork and I was on a mission. It’s bad enough when you are fighting for your life that you also have to beg and grovel to get treated. I was prepared to argue my case, yet when I got there my oncologist and the surgeon had discussed it and agreed that since I had remained stable for awhile he would attempt surgery.

 

March 26, 2010 it was removed via a thoracotomy. They had noticed another tiny spot on scans and decided to also do a wedge resection. That tiny spot was benign.

 

Now what? Fred was still making my clones. They said they would contact me when they were ready. I explained to them that I had surgery, which made another problem-no measureable disease-no trial. They would have no way to measure the success or failure without some melanoma.

 

They also expected it to grow back. So when the 4 months of making the army of clones was completed they called me back. I was still surgically made NED. They said they would freeze them down until such date when I progressed and could use them.

 

I wanted a trial- I needed a trial-I e-mailed Dr. Rosenberg at the NIH and within a couple days June Kryk and Kathleen Morton telephoned from the NIH. I went to be assessed in June 2010-again without measureable disease, no trial. They said my melanoma would return in a couple months and I would then qualify for the HD-IL-2 trial.

 

I spent every waking hour looking for a clinical trial. I wanted to be in one before it returned.

 

It made no sense to me that I needed measureable disease; obviously I had melanoma and it was obvious to everyone that it was coming back.

 

On Aug 6, 2010 I found my trial! It had to be posted on Aug 5, 2010 late night because I was checking and rechecking every melanoma trial  at www.cancer.gov for stage 4.

 

I went through all my medical records I had scanned on my computer, picking and choosing what I wanted to send with an e-mail to Dr. Weber. The trial was called “Phase I Study of Anti-PD-1 Human Monoclonal Antibody MDX-1106 and Vaccine Therapy Comprising gp100:209-217(210M) Peptide, MART-1:26-35(27L) Peptide, gp100:280-288(288V) Peptide, NY-ESO-1 Peptide, and Montanide ISA 51 VG in Patients With Resected Stage IIIC or IV Melanoma” and it was at Moffitt .

 

I finally attached all my files and e-mailed Dr. Weber in the wee hours on Aug 7 at 1:51 AM . He responded Saturday afternoon at 1:51 PM…Exactly and I mean exactly 12 hours later. ( I still have my e-mails!!) His e-mail reply was short and to the point “Mrs. Luckeroth: If you are HLA A2 positive, and if your tumor expresses one of the antigens that we include in the vaccine, then you may well be eligible for this promising trial. Jeff W.”

 

The trial hadn’t opened yet and they were only going to have 30 people. Time was of the essence!

 

We flew down to Florida for my initial assessment on August 27,2010. I was able to provide my HLA results. Moffitt would contact Fred Hutchinson about my tumor assay and get my slides from Mayo.

 

Now we wait.. I still needed one of the antigens. If Fred hadn’t done an assay then they would need to test the slides from Mayo. More wasted time… I wasn’t sure what antigens were at that time but I contacted Fred Hutchinson myself and asked if they did a tumor assay. They informed that they did and attached it to  the e-mail on Sept 8, 2010–

 

all it said was

NY-ESO-1 Negative

Mouse IgG1, non-immune Negative

HMB45 (gp 100) Uniformly Positive

MART-1(Melan A) Uniformly Positive

Tyrosinase Uniformly Positive

On the same day I sent it on to Dr. Weber and his response was: “The melan-A and the gp100 are positive, so that’s enough to get you on the trial! Jeff W.”

 

On Tuesday September 28 -I had apheresis, blood work and round one of my trial. Six injections in one thigh consisting of two with gp100:209-217(210M) Peptide, two with MART-1:26-35(27L) Peptide, one with gp100:280-288(288V) Peptide, one with NY-ESO-1 Peptide in Montanide ISA 51 VG along with the infusion of an Anti-PD-1 called MDX 1106 aka BMS-936558.

 

I am going to do this for two 12 week cycles and if all goes well then I will get booster IV’s of Anti-PD 1 for 2 years. It’s a 30 month trial.

The summary of this trial says:

This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.

Patients receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes and vaccine therapy comprising gp100:209-217(210M) peptide, MART-1:26-35(27L) peptide, gp100:280-288(288V) peptide, NY-ESO-1 peptide, and Montanide ISA 51 VG subcutaneously once in weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive anti-PD-1 human monoclonal antibody MDX-1106 every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Blood and serum samples are collected periodically for immunology and pharmacokinetic studies.

After completion of study treatment, patients are followed up for up to 2 years.

It is Aug 21, 2012. It is also week 99 of my trial. I remain NED ( no evidence of disease). I have my next treatment coming up with the scans on Sept 5. After that I have 2 more treatments within the following 6 months.

The last treatment day- Moffitt is going to party with me! I will bring the food.

I also have plans to go over to the Mayo Clinic and visit my old oncologist, the nurse practitioner and my surgeon! I want to also make a trip to my radiation oncologist and my quack medical oncologist in North Dakota.   I want to tell them that while they gave up on me- I didn’t.

This entry was posted on August 21, 2012. 2 Comments