Reynsie48

Jean, I can so empathize with you. Often before I start the wash, I will bury my face in one of Ron's shirts and think what if...... I think I would be very much like you, and I am glad that you posted Sandy

Merck KGaA Resumes Stimuvax Clinical Program in Lung Cancer * FDA lifts clinical hold on START clinical trial Darmstadt, Germany, June 17 2010 –Merck KGaA and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine*) clinical program in patients with non-small cell lung cancer (NSCLC), which includes the Phase III studies, START(a) and INSPIRE(. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees. “Merck remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients,” said Dr. Wolfgang Wein, Executive Vice President, Oncology of the Merck Serono division. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to partially lift the clinical hold it placed on the Investigational New Drug (IND) application for BLP25 liposome vaccine in March 2010 and allow the START trial to be resumed. “Merck worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program,” commented Dr. Bernhard Kirschbaum, Head of Global Research and Development of the Merck Serono division. “We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries.” The study that remains on clinical hold by the FDA is the Phase III STRIDE© trial in advanced breast cancer. Merck will continue to work closely with health authorities, including the FDA, to decide the next steps for this trial. "The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in the treatment of these currently underserved patients," said Dr. Frances Shepherd, Director of the Medical Oncology Princess Margaret Hospital in Toronto, Ontario, Canada, and Coordinating Investigator of the START trial. Merck temporarily suspended its global clinical program for BLP25 liposome vaccine in all recruiting studies worldwide following the clinical hold put in place by the FDA in March 2010. The clinical hold followed a suspected unexpected serious adverse reaction (SUSAR) of encephalitis, observed in a patient enrolled in an exploratory Phase II trial of BLP25 liposome vaccine in patients with multiple myeloma. To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures. a) START: Stimulating Targeted Antigenic Responses To NSCLC INSPIRE: Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response c) STRIDE: STimulating immune Response In aDvanced brEast cancer * BLP25 liposome vaccine is an experimental therapy that has not been approved for commercial distribution. About Stimuvax Merck is investigating the use of Stimuvax® (BLP25 liposome vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status for NSCLC in September 2004 by the FDA. Merck KGaA obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA. Stimuvax is being developed in Europe by Merck. In the United States and Canada, Stimuvax is being developed by EMD Serono, an affiliate of Merck KGaA. The START study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS). The INSPIRE study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enrol approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan. Study participation is expected to last for a minimum of 24 months. STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study.

Prayers for Katie and Rick! Sandy

A Happy and Blessed Easter Sunday to you too Judy and to each and everyone on the board from Guleph Ontario. It is beautiful here, hot in the sun, cool in the shade and I walked around the hospital grounds after eating my lunch out in the sun sitting on a bench. Unfortunately I have to work my yearly month of days in April but it is so nice to look forward to the beautiful weather that will be waiting when I finish at 3pm and the Hubby that will be waiting for me to enjoy a nice Easter supper out with. This is one of those times that I am reminded that there are still many special times to be thankful for! Sandy

Barbara, Tears are good! I can only hope to follow your and Bill's example if and when the time arises. For now, I wish you peace. Sandy

Barbara, I am so very sorry to hear this. I have followed your's and Bill's story for so long I feel like I have lost him too! Rest in Peace Bill. Sandy

Barb, I wish you continued strength during your journey with Bill! Sandy

Bonnie, I am so very sorry for your loss. Sandy

From what I understand from Ron's trial nurse is that yes, the Start trial has yet to reach it's quota of patients and that it has been somewhat difficult. Many who might qualify decide not to take a chance on the randomization of 2/1, and others leave the trial because of progress in their disease. Ron asked his Oncologist a few visits back, how long he might stay on this trial and of course the answer is indefinitely, or till progression or you choose to leave it. I guess until the maximum number of patients has been enrolled, they don't reach randomization so he feels we may be looking at years down the road. We are aware that Ron was treated very aggressively because of his good performance rating when he was first discovered to have cancer, stage 3 (Squamous), unresectable not only because of mediastinal involvement but because the original mass was around his pulmonary artery and the risk of "nicking" the artery during surgery and bleeding to death was too great. His radiation oncologist (who was the first one to give us the grim news of 6 to 8 months without treatment, 12 to 18 months with) was also the same Doctor who all along said that Ron was one of a few patients that he felt might just "squeak" through the door, and this was from one of the first appointments, and months pre trial. As Dr. West has pointed out, stage 3a NSCLC is treated with curable intent and therefore Ron may have done well either way. For myself, I enjoy the continued extra surveillance that comes with participation in the trial, and although the hope is to maintain the status of no evidence of recurrent disease that he achieved around December of 2008. Today Ron became 64 years old and we head out for the Doctors’ in a couple of hours, and then to the Cancer Centre on Wednesday, but we really don’t mind sharing birthdays with the “Docs”, just so very glad that the birthdays are there to share. Sandy

(((((Bonnie))))) Prayers for you, for Howard and for your children to help you all ! Sandy

Lynnie, Such a beautiful tribute to your Father. My deepest sympathies to you and your family. Sandy

Hello Barbara, So sorry to hear that Bill is having problems again. I am no where near an expert but if it were my husband, I would push to get an antibiotic for the infection along with a regimen for treating and dressing the bed sore. A bedsore left untreated with or without an infection will get worse and sepsis is a real worry but as well, they can become extremely painful. I am not sure whether or not this would be considered aggressive treatment but in my book would not only make sense but also be competent medical care. It has been some time since I have nursed but even back when we worked on geriatrics you treated a bed sore and or an infection with whatever was necessary. Just my thoughts, Sandy

Melanie, such great news to hear! Congratulations Sandy

Wow! Happy Birthday Geri Sandy

Dear Anne, I am so sorry that you are going through this and I wish I had not only some wisdom for you but some answers as well. It pulls at my heart strings as I could very easily end up in a similar situation and it has often crossed my mind. I too work outside the home and we put a huge dent in our savings for me to take 3 months off and go with Ron when he first went through treatment. This is not something that would be easy to do again and to amplify the problem by Ron actually thinking I didn't want him home would be a breaking point for me. Up here where I am, at our centre, they are trying to treat the cancer patient and the cancer patient's family as a whole as they recognize that it is a disease that deeply affects the whole family and I would hope that dealing with life's necessities such as working to pay the bills, keep up health insurance, stay sane, etc., etc., would be recognized as a priority but obviously there is a lot of work to be done there. This is a problem that will continue to get worse as younger and younger people end up with lung cancer and other cancers. I accept the fact that if the situation were reversed and I was the one with the cancer, that a fact of life would be Ron continuing to daily work and that I will have to manage a fair amount on my own but at this time can't even imagine how we would cope. As it is, we consider Ron a luckier one as he is back to work, it has not been easy as he tires and will soon be 64 but he is the one with the benefits and because he had good benefits they were able to "rehabilitate" him and exert a lot of pressure on him to return to the work force full time as insurance companies have yet to recognize or be able to measure the long lasting after effects of treatment. I hope that you are able to persevere in finding a solution that leaves you feeling safe about your husband while you continue to be the bread winner. You don't need any extra stress! Best wishes and good luck. Sandy

Welcome back and keep up the good work! Sandy

Patti- I have and will continue to say prayers for your scans, may you keep showing cancer who is the boss, it is too late to stop now! If anyone can do it, Patti can.

Oh Barb, I so haven't wanted to check for updates on your and Bill's journey as I have dreaded the natural progression that your "taking things one day at a time" has been referring to. My heart goes out to you, I can only imagine the strength that this is taking and the heart ache you are going through. I will pray for you most certainly and for Bill, and I hope that I am not mistaken in thinking that Bill sounds at peace and not in so much continuous pain from his shoulder. I wish for you continued strength and support, and whatever it takes to help you continue to get through this journey. Bill has fought so long and so hard and you have been there by his side and you both must be so very very tired. I must quit this crying and get rid of any sign of red eyes before the big Guy gets home from work!

Patti, I know that your posts have helped me see over the last three years so many times, as to what can be accomplished in the fighting mode. Your posts have in so many ways, helped me to be a better supporter to my husband I think, or at least better able to picture and understand what is going on inside of his head and his body and the effort that keeping on, keeping on takes on a daily basis. I too so admire what you say, what you do and how you do it! Sandy

Melanie, May it soon be over and done with and you will be on your way to recovery! Sandy

Barb, I am so glad that Bill is home, and I can almost picture his room from your description. I wish you both continued strength as you continue on in Bills five year journey. Sandy

This is so good to hear! Without hearing your voice, your words sound so happy and full of relief. The word "Home" says it all, can you just imagine how Bill is feeling..... This is just the best news. Be well and be happy. Sandy

Hi Judy, I was wondering the same thing about how things are going for Barb and Bill, and I noticed today that although Barb has not posted an update, she has updated Bill's story (history) as recently as today I believe. Sandy

Judy, Doesn't it feel good to have a good cry though once you get past the swollen eyes. I think it is what saves us from "boiling over", lets some of the built up pressure off and almost refreshes your soul. Then the next day you can get back to keeping on keeping on. I so admire your spirit and hope you find the strength to get through the rough patch and heartache. Sandy

Hi Michelle, I don't know if there is anything I can say to help you during this horrible time but I thought I would pass on the way my husband looks at things and truly believes. He handles the fact that cancer invaded our lives much better than I do or ever will. Ron is not a partiularly religeous man but he is a Good man and a good person. He believes that there is a master book somewhere (so to speak) and that everyone's name is on a page of that book pretty much the day you are born. If the page comes open that holds your name, then there is absolutely nothing on this earth that either you or anyone else can do to stop that from happening, it is going to happen. If however the page with your name on it has yet to be opened, then it is not your time and you could literally walk in front of a bus and you will survive it. My sister Winn, seemed like a zombie the first 2 to 3 years after Frank's passing from Bowel and bone cancer, and she tortured herself with doubts and what ifs. His was neither a gentle nor a welcomed death, he did not want to die and she wanted him comfortable. There was much more than that, but I think that is what she found the hardest to deal with. Anyway, as I said in an earlier post, Win remarried in 2007, (Frank passed in 2000) and she married a very devoted family man who had lost his wife to cancer as well. All though we all love Win who was as much a mother to us as an older sister, we were all very surprised at this turn of events but so very happy for her and her new husband both. In the back of my mind, I think my goodness another tradgedy waiting to happen, I am not sure I could do this but I guess what I am getting at is........these two people shared horrible grief and were able to after time rise above it and find happiness again and grab for that happiness even if it means that they may go through this hurt all over again. It is still so very very early and I can't even imagine how you feel right now, but I know I have watched people I love very much go through similar circumstances and it is possible, you just can't see it yet. I wish for you to have peace in the New Year. Sandy