Baseline CT finally scheduled.

After 17 days of phone calls we finally have a CT scheduled for Thursday morning the 26th. This will be done at MUSC. Which is why it took so long to get anywhere, 2 hospitals had to coordinate to get the scan done.
This will be the first step in moving forward with the clinical study. After the CT results are sent to Duke, we will have to go up there to get the EKG and Blood work. After all that is done the results are sent in to Novartis and we find out if we get approved to be in the study.
Then I would go back up to Duke again if we get approved and actually get the medicine and start treatment.
So that is the state of things right now. The CT scan has been the bottleneck. After that is done things should start to roll.
Have a good day.
Greg

Meet Dr. Morse at Duke

Michael A. Morse, MD, MHS
Department: Medicine
Division: Medical Oncology

Training:
M.D., Yale University School of Medicine, Connecticut, 1990

Residency:
Internal Medicine, University of Washington, 1990-93
Hematology/Oncology, Duke University Medical Center, North Carolina, 1993-96
Other Degrees:
M.H.S., Duke University Medical Center, North Carolina, 2000

Clinical Interests:Gastrointestinal malignancies, hepatic tumors, immunotherapy
Research Interests:We are studying the use of immune therapies to treat various cancers, including gastrointestinal, breast, and lung cancers and melanoma. These therapies include vaccines based on dendritic cells developed in our laboratory as well as vaccines based on peptides, viral vectors, and DNA plasmids. Our group is also a national leader in the development and use of laboratory assays for demonstrating immunologic responses to cancer vaccines. Finally, we are developing immunotherapies based on adoptive transfer of tumor and viral antigen-specific T cells.

Our current clinical trials include phase I and II studies of immunotherapy for: patients with metastatic malignancies expressing CEA, high risk resected malignancies such as breast, colon, and lung cancer. We are performing a clinical trial of adoptive transfer of CMV specific T cells in conjunction with the BMT program.

My clinical area of expertise is in gastrointestinal oncology, in particular, the treatment of hepatic malignancies, and malignant melanoma.

For more information, see http://arcadia.mc.duke.edu/LyerlyLab/body_index.html

Key words: dendritic cells, immunotherapy, vaccines, T cells, gastrointestinal oncology, melanoma, hepatoma

Found More Study Details on the Novartis Site

Finally found something on the Internet regarding this study. It is from the Drug company's Novartis website.
Here is the text:
Thanks,
Greg

RADIANT-1: Pancreatic Neuroendocrine Tumors (Islet Cell Tumors) after chemotherapy failure Study CRAD001C2239
Novartis Oncology is conducting a clinical research study to find out if an investigational drug is safe and effective in people who have advanced pancreatic neuroendocrine (cells producing hormones) cancer. This cancer is also known as islet cell carcinoma. Patients must have previously received an adequate course of chemotherapy (i.e. at least 3 consecutive cycles or months of treatment with the same drug or regimen). Patients should also have documented objective progression of disease by RECIST criteria while receiving cytotoxic chemotherapy or documented progression at any time after receiving an adequate course of chemotherapy. The purpose of this clinical research study is to learn if the investigational drug can shrink or slow the growth of advanced pancreatic neuroendocrine tumors. The physical state of participants, changes in the size of their tumors and laboratory findings will be taken to help determine the safety and effectiveness of the investigational drug. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). Trial phase: Phase 2Participation Duration: Participants will visit the study clinic and draw blood every 2 weeks during the first month; then once a month until study completion. Radiological scans (CT and/or MRI imaging) are expected every 3 months. Study will last approx 16 months.Protocol Number: CRAD001C2239

Duke Univ Medical Center Consultation

Went to Duke this morning for the first time.
What a beautiful building. First rate facility.
We talked with Dr. Morse. He went through my history briefly. We talked about all the procedures we have done in the past, all the different drugs we have been on and all that stuff.
After talking about that he agreed that this study medicine that they have is the way to go. It is called RAD-001 for right now. It is being done by Novartis.
I will be the first patient they have at Duke doing it, if all goes through on the application process. They kept talking about what a brave thing it was to take the experimental drug, I don’t know what that is all about, like maybe it is going to grow a third arm on me or something.
Anyway, what we have to do to get started is do ANOTHER CT scan, an EKG and blood work. Then if all those prescreen tests come out ok and to their liking we have to finish with the paperwork.
There are also some insurance questions that have to be worked out before we go forward. Seeing as how this is out of state adds a whole level of complexity to the insurance scenario.
After having all the screening tests done and approved, how the thing will work is, I will get the prescriptions, which are 2 pills a day. Then have to go every two weeks for several cycles and have blood work done at Duke so they can monitor my progress. Then after a while it will reduce to once a month for the blood work. This will last for 4 months and then they will do another series of scans and tests to see if there has been any progress or whatever.
If I am seeing good results then they will do an extension of the drug. Obviously they will want you to stay on the drug if it is doing you some good. This will last for another 3 months, and then we will scan and test again, and if all is well go another 3 months.
There are potential side effects of rash, mouth sores, fatigue, respiratory issues, nausea, low blood sugar, lowered electrolytes, and overactive liver functions possibly damaging the liver tissue.
They have a side experimental study going on called a bio-marker study. It tracks DNA predispositions and cancer treatments that may help people in the future get better diagnosis of what types of drugs may work given certain genetic markers. So I am signing up for that one as well, there is really no extra work to be done on my side, just a few more vials of blood and then they will catalog the DNA. It is really just an extra consent form.
So we are waiting to hear back on some insurance issues and scheduling concerns. But overall it looks like things are moving forward and we will be starting the study as soon as we can get the prescreening tests done and we get the nod that I am truly eligible given my conditions.
We are pretty excited and are looking forward to getting this done.
Cindy did all the driving to and from Duke. She has really matured in terms of travel ability through the last few years. I was very tired after the meeting which lasted about 3 hours, and slept the whole way back home once we got to recognizable highway. She drove the whole way up except for about 20 mins, and the entire way back. She used to be the kind of wife that would just sit and look at the scenery and would only drive on trips to give me a rest period. But she has completely taken over behind the wheel now. We still need to work on the navigation skills, but as long as I am awake that is not a problem. Such a relief that I know she can handle the driving given all the trips we are going to be making up there over the next several months.
That’s all for now.
Love,
Greg

Off To Duke Soon

Well after many phone calls and coordination we are off to Duke for an appointment Monday the 9th. This is being considered a "second opinion" by Dr. Morse, whom we are going to see.
They want to look at the whole history all the way back to the original diagnosis, and see if the study is the thing for me to do or if there is some other path or treatment he would recommend.
So I will let you know how that works out after the visit.
Good news is, Duke is close to family and friends relatively speaking, considering the other sites doing this study. So we may be able to squeeze in some short visits around these appointments.
Stay health, spay or neuter your pets and help keep Hillary out of the white house.
Love,
Greg