Carpenter and Husband Disqualified From Clinical Trial

A few short months ago, in the Winter of 2002, 45 year-old Keith Marshall and his wife Kathy were coming up on 20 years of marriage together. He and Kathy had started talking about retirement, and building a house on a pretty spot by a nearby lake. He continued to work hard as a skilled carpenter, but after work Keith and Kathy were always doing something. Packers games and refurbishing antique bicycles filled the long, brutally cold Wisconsin winters. Summer's warmth brought festivals and "the three Bs": beer, brats, and baseball. He was as robust physically as their lives were full. He rode the bikes he fixed. He transformed the hill in his backyard into a multi-tiered terrace through sheer strength, manhandling boulders of several hundred pounds.

They could never have imagined what was about to happen.

BLOATING AND ABDOMINAL DISCOMFORT LEAD TO DIAGNOSIS

It started on March 1, 2002, when Keith experienced the onset of bloating and abdominal discomfort. He took Simethicone for relief of gas with mild improvement. He eliminated several foods from his diet including high-fiber vegetables, radishes and onions, and gained slight alleviation of his symptoms.

Beginning around March 8, he noticed progressive, increased abdominal swelling and discomfort. His discomfort was located on both the left and the right sides in the upper and middle portions of the abdomen. He had difficulty sleeping and loss of appetite, but no nausea or vomiting.

On the morning of March 11, Keith presented to his primary physician, who referred him to Dr. David Engstrand, a surgeon. Dr. Engstrand saw Keith the same day at Elmbrook Memorial Hospital in Brookfield, Wisconsin. An abdominal CT scan taken on March 12 at Elmbrook Memorial revealed among other things the presence of "subdiaphragmatic collections of liquid" in the right and left "gutters" of the abdomen and some thickening of the omentum. No tumor could be appreciated. A colonoscopy performed the same day detected no abnormalities.

Still unable to explain Keith's continuing symptoms, his physicians recommended a laparoscopy with the possibility of an exploratory laparotomy. Dr. James Burhop performed the surgery on March 13 at Elmbrook Memorial. The general laparoscopy detected fluid throughout the abdominal cavity. On closer inspection, Dr. Burhop could see "studding" of the peritoneum throughout the abdominal cavity, but most prominently in the lower abdomen.

The peritoneum is a thin layer of tissue encasing the abdominal organs. The pleura is the same kind of tissue which encases the lungs. Mesothelioma affects the peritoneum, pleura, and other tissues, and physicians experienced with the cancer describe the appearance of nodules spread diffusely across this thin tissue with such phrases as "studding", "blisters", "sandpaper", and "cottage cheese."

Dr. Burhop surgically removed two of the peritoneal nodules and submitted them to the pathology laboratory for "frozen section analysis" (FSA), a relatively quick test which is completed during the surgery to confirm the presence of cancer. FSA of two excised peritoneal nodules confirmed that this indeed was a malignant tumor.

Dr. Burhop removed the laparoscope, made a midline incision and saw significant studding of the entire peritoneal cavity. He surgically removed a very thickened, nodular portion of the omentum and several more "peritoneal implants." Slides, stains and blocks from the resected tissue were forwarded to the Mayo Clinic in Rochester, Minnesota for analysis., but based upon the tumor's appearance, Dr. Burhop was convinced this was mesothelioma.

Five days after the surgery, Keith was discharged from the hospital without a definitive diagnosis. On March 25, 2002, Mayo reported its diagnosis of malignant mesothelioma based on immunohistochemical staining.

ANTI-MESOTHELIN IMMUNOTIXIN

The Marshalls were dumbfounded. As Kathy wrote shortly after Keith's diagnosis, "He is so healthy looking and strong that it just seems like someone has made a horrible mistake." Kathy began desperately looking for treatment for her husband of 19 years. She admits she was "grasping at anything I can as I am just devastated by this."

On April 1, Keith consulted with the Waukesha Regional Cancer Group. A physician there recommended he apply for candidacy into the Phase I Study of SS1 (dsFv)-PE38 Anti-Mesothelin Immunotoxin trial at the National Cancer Institute (NCI) in Bethesda, Maryland. The Marshalls applied and learned on April 2 that Keith had been accepted into the program.

In preparation for the study, Keith underwent several tests, including a blood test. One of the blood tests showed that some of his antibodies would destroy the toxin in the Anti-Mesothelin. This toxin is vital in killing the cancer cells. It was further explained to the Marshalls that there were low levels of antibodies and that if they were to give him the first round of treatment it was very possible that Keith's body would produce more antibodies that would destroy all of the toxin.

NCI asked Keith to provide another blood sample. On April 29, the Marshalls went to the Waukesha Memorial Hospital and had a blood sample drawn, which was promptly shipped to the NCI. The results of the test were returned almost a week later. On May 8, Keith learned that he would not be included in the NCI study.

CISPLATIN AND GEMZAR

The next day, Keith met with the physician who then set up a chemotherapy program for him. On May 14, he underwent his first chemotherapy treatment. Chemotherapy has not been easy for Keith. His regimen consists of Cisplatin and Gemzar, and as of July 1, he had received two treatments with the first and five treatments with the second.

Normally, the treatments are given on alternating weeks to allow the body time to recover from the brutal effects of Cisplatin. Keith was scheduled to receive both drugs during the week of June 24. This time, his body was too weak to endure the hammering that chemotherapy can inflict and was postponed until July 2.

Before he could receive the next treatment, however, Keith's doctors implanted a Medi-port on July 1 in his upper left chest area. A Medi-port is a device that creates a semi-permanent "hole" in the body that taps directly into a vein. The device facilitates easier and more rapid drawing of blood and administration of chemotherapeutic drugs. Keith's treating staff had encountered difficulty finding his veins, and the Medi-port was deemed the best solution. Keith initially balked at the idea, calling his consent to the procedure "giving in" to the disease. Kathy intervened, and on July 1, he underwent the surgery.

A June 10 CT scan revealed that Keith's tumor had not shrunk. He will undergo another CT scan on July 15. He and Kathy are hoping for better results.

"CRAZY", INSPIRATIONAL DETERMINATION

Keith's body seems to be dissolving. His hair is thinning. He moves slowly, less forcefully, but he keeps at it, stubbornly and stoically persistent, willing himself out of bed, to sit up, to eat, even to pull weeds from their gardens. Kathy cannot help but feel amazed and inspired by her husband's "craziness", his intransigence, his stubborn refusal to give in to the disease. So she refuses to give in either, relentlessly following what she calls "the maze" of treatment options online, on the phone, and in consultations with doctors. And she prays all the time, her prayers intermingled with those offered by family and friends.

She says she will keep pushing until the day when he no longer can. She hopes it doesn't come to that. Voice breaking, she says, "I just don't want to lose him."

We will keep you posted on this determined couple.

*** POSTED JULY 12, 2002 ***

An Update -- 4/23/03

I wanted to tell you that Keith's oncologist got the approval to use the Alimta for Keith in Dec.2002 and he has had 5 treatments for the Peritoneal Mesothelomia. Today the GI Surgeon who was the original one to find the cancer in March 2002 did laproscopic surgery and found that the tumors are 50% reduced. Keith had been started on Gemzar & Cisplatin in May 2002 which he received until the end of August. He had laproscopic surgery done then and it was found that the tumors were at that time 50% reduced. But because Keith was having such an awful time tolerating the Cisplatin the oncologist decided to just try the Gemzar. So after 2 1/2 months of that he had another laproscopic done and the results looked the same from the surgery in August.

The oncologist gave Keith a few months off to recuperate, while he was going for the OK to use the Alimta. All of the laproscopic surgeries have been done by the original GI Surgeon as the oncologist feels that he was the one to know what it looked like at the start and would be the best to judge on the progress. So, if my math serves me correctly the tumors are 75% reduced from when they were first discovered which gives me great hope.

Thanks again for your e mails I really appreciate them and please feel free to let others know about Keith's progress with the Alimta. It seems to be much more gentle then some of the other chemotherapy drugs out there and look at the results we have so far.

Kathy Marshall

An Update -- 5/29/03

In a recent update from Kathy, she advised that Keith's doctor had decided to add Carboplatin in conjunction with his Alimta. Previously, Keith had been taking Cisplatin with the Alimta. He had his second treatment using the Carboplatin/Alimta cocktail last week and he seems to tolerate the Carboplatin much better. He still has a rough period for three or four days after his treatment, but he quickly rebounds and gets back into his daily routine.

Keith's doctor advises that after two more treatments he would like Keith's GI Surgeon to perform laporscopic surgery again. It will be the third surgery for Keith. Chemotherapy and surgical invention have reduced Keith's tumors by 75% and they are optimistic that this treatment cycle will rid his body of these hideous tumors. Kathy prays for this miracle every night.

It will be a busy summer for the Marshalls. Kathy's parents are coming to visit in July and hopefully her cousin and his wife from Montana will be joining them. If Keith continues to stay on the same recovery path, they hope to travel to Phoenix, Arizona in October to visit their friends.

We will continue to keep you posted on this determined couple.

An Update -- 5/ 17/04 (From Kathy)

Hi,

It's been awhile and so much has gone on around here. Keith started the Alimta Jan. 2003 and took that for 4 treatments and then he had laparoscopic surgery and it looked like it had reduced the tumors.

We completed 5 treatments of Carboplatin with the Alimta for 5 treatments and had laparoscopic surgery again and the results were wonderful, the size of sesame seeds was what was left and maybe about 10% was all that was left. He had his last treatment Sept. 2003, so by now he is feeling better, getting his strength and stamina back and just generally feeling good.

We went to MD Anderson in Jan 2004, Keith's oncologist wanted us to meet with a Dr. Brown and hear about this treatment that they do. They go in and peel away layers of the tissue in the peritinum and then do a chemo belly wash. Well, we went and met with Dr. Brown and a surgeon, heard what they had to say and Keith said "No thank you". It is pretty radical and very hard on your body and he just did not feel that it was the right thing for him, especially right now.

One thing that they did mention was taking Celebrex, which is usually used for arthritis but they thought that it could keep the blood flow from the tumors. So, we told the oncologist that and he started Keith on it right away. On March 31st Keith had his 8th laparoscopic surgery in 2 years and everything is still the same as it was back in Oct 2003, small sesame seed size and no new growth. I was sitting in the waiting area with Keith's sister, her husband and 2 of my very good friends who had showed up to lend support. When the surgeon came out and told us that I could not hold in my happiness, I just let out a shout of "YES" It was 2 years ago on March 13th that Keith was diagnosed with this and after reading about this disease on the internet I really did not think that he would be here 2 years later.

I just thank God for getting us to a wonderful oncologist, getting the OK to use the Alimta (I think the Alimta and Carboplatin) really made a difference and for all the wonderful people we have met along the way on this journey we have taken. Keith is on so many peoples prayer lists that, that had to make a huge difference, I just really feel we are truly blessed.

One night Keith was really depressed about this whole thing as it really is hard to live life with something like this hanging over you. I sat down with him and said "Ya know, I try to look at this as having our glass not half empty but half full. Think of this, at the first sign of a problem your Internist sent you straight to the hospital where after 3 days you were diagnosed, not everyone is this lucky. You got a wonderful Oncologist who doesn't have an ego, he is always looking for other avenues of treatment and looking to others for help if need be. Your surgeon is wonderful, you really like him and even though him and your oncologist don't work together the oncologist doesn't want you to switch to someone else because he was the first one to see what was going on inside. We have the support of so many people and we have reconnected with old friends, that is wonderful just by itself. " After this talk Keith seemed to feel better about things, not to say that once in awhile he doesn't get down about things but I think it helped to put things in a better perspective.

On May 24th we are taking a vacation to London England. I decided in Nov of last year that we had always wanted to go there and said to myself, what are we waiting for? So, I booked everything and gave it to Keith for Christmas. He has always wanted to go to England and drink beer in a pub, see the tower of London and go to the flea markets that they have all over. We are getting more excited as the time draws near, I'm getting more nervous as I am not that fond of flying especially over an ocean for 6-7 hours.

I had a nice time in Washington DC. I did get to meet with Senator Kohl and felt really positive about that meeting. He really seemed to listen to us and asked us questions, I brought up that my main concern was that there was no money for research and that really needed to be addressed. I asked him what was going to happen in 15-20 years when the people of New York City started to show symptoms of this disease because the twin towers were loaded with asbestos. What about the children that live there and the "Heroes" of 911, what will we tell them when they come to our medical centers for help and treatment "Sorry, we didn't think about that?" At that he looked at his assistants and told them to look into that, they all seemed startled about the possibility that the twin towers had asbestos in them. I knew because I read an article in a medical magazine and that Dr.s in that area were quite concerned about this potential problem. Even now people are having problems breathing the air in their buildings because no one has thought about cleaning out the vents and heating/cooling ducts. It is a scary thing that asbestos could be just circulating through the buildings all the time because they have not cleaned the ducts out. Anyway, I had a good time and felt good about the experience and told them if they wanted me to come back another time I would. I know that this fight is probably not over so if I can help I will. Some of the people that Keith works with know Senator Kohl and they all emailed him, some even called him (Keith works for the Milwaukee Jewish Federation). They have been so supportive through out this whole thing.

Well, I think I am done, have a wonderful summer.

Kathy

An Update -- 4/5/05 (From Kathy)

This is going to be the hardest email I have ever sent but I promised to keep all of you informed so here goes. The week we were in NYC March 8-11, that is when they did a CT Scan and had gotten blood out of Keith's abdomen ports. The CT Scan looked as if it showed more disease and that the chemotherapy solution was not getting to the areas that it needed to but was pooling. The reason it was pooling is because Keith has so much scar tissue from previous surgeries that it actually was catching the solution and keeping it from getting to all areas in the abdomen. So, we went back the week of March 22nd and Keith had a CT/PET Scan to confirm that and they discontinued the chemotherapy treatments. Dr. Taub said when the chemotherapy pools like it was doing it could actually cause more damage to the surrounding tissue and we don't want that. He suggested that Keith have conventional IV Chemotherapy. He had already called and spoke with Keith's Dr. here in Waukesha and talked about using 3 different chemo drugs.

Keith had an appointment with his Dr. here on March 29th. Keith and Dr. LeMarbre made the decision to not have any more chemotherapy treatments. Dr. LeMarbre spoke with Keith about a quality of life and the fact that these 3 drugs not only would make him sick,fatigued and all of the other things that comes with chemotherapy it also had a small probabilty of doing much good. He said that it seemed everytime Keith had chemo treatments the tumors came back stronger and more resistant to the next round of chemo. Dr. LeMarbre has asked myself and Keith's sister, Candace to look for treatments of Gene therapy with no chemotherapy involved. Keith is just so tired of feeling so bad that he would like to gather some strength back and hopefully have a nice summer for a change. Keith still needs to get the ports taken out of his abdomen and that will be done here in Waukesha.

Keith seems to be at peace with his decision and therefore so am I. It is not easy and as I told him "I support your decision but I'm going to have some bad days". But it does seem as if a huge burden has been lifted off his shoulders. Now we are going to just enjoy each other, family and friends. Maybe do some traveling and see some things we always said "When we retire I'd like to see that" I have inquired about retirement, but at this time I am not going to make any big decisions like that. And, Keith needs to gain some strength before he could travel and enjoy it. Keith also applied for Social Security Disability this past week, so he will not be returning to work.

I ask if you would all keep Keith in your prayers and I thank all of you for your support and love that you have shown us both.

God Bless all

Love

Keith & Kathy

Keith Marshall passed away on October 9, 2005