Are certain drugs more effective against some types of prostate cancers than others? Researchers know that not all therapies work for all patients – the next question is to figure out how to match the right treatments with the right patients.
A new clinical trial is testing whether an experimental drug can maximize the effect of current treatment and whether matching that drug to a genetic anomaly can lead to better, more personalized treatment for prostate cancer. The trial, led by investigators at the University of Michigan Comprehensive Cancer Center, is being conducted at 11 sites throughout the country. Continue reading →
As a Cancer AnswerLine nurse, I’m often asked by a caller, “Can I have treatment for my cancer with stem cells? I have read that U-M is involved with stem cell research.” This simple question has a very complex answer.
All of the blood cells in your body start out as young (immature) cells called hematopoietic, (or blood-forming), stem cells.
Stem cells mostly live in the bone marrow (the spongy center of certain bones), where they divide to make new blood cells. Once blood cells are mature they leave the bone marrow and enter the bloodstream. A small number of stem cells also get into the bloodstream. These are called peripheral blood stem cells. Continue reading →
Many types of tumors can start in the thyroid gland, which is in the front of the neck, below the Adam’s apple. Most of them are benign (non-cancerous) but others are malignant (cancerous), which means they can spread into nearby tissues and to other parts of the body. The two most common types of cancer are papillary carcinoma and follicular carcinoma. There are other types of thyroid cancer, which are rare.
Thyroid cancer is commonly diagnosed at a younger age than most other adult cancers. Nearly two out of three cases are found in people younger than 55 years of age. About 2% of thyroid cancers occur in children and teens.
Ronald J. Koenig, M.D.
Most thyroid cancers can be cured by surgery and radioactive iodine. However, thyroid cancers not cured by those therapies present a problem. As a rule, thyroid cancers do not respond well to chemo. But unlike standard chemo drugs, targeted drugs attack certain targets on cancer cells. The targets they attack can be present on normal cells as well, but the goal is to find targets that help cancer cells grow and thrive.
Ronald Koenig, M.D., Ph.D., professor of internal medicine at U-M, heads a research team focused on developing targeted drug therapies for thyroid cancer. He talked with mCancer Partner about a new clinical trial that is opening enrollment for certain patients with thyroid cancer.
mCancer Partner: Can you tell me about your newest clinical trial?
Dr. Koenig: In this new trial, to be funded by the National Cancer Institute, we are investigating whether a drug, Actos (pioglitazone), is useful in treating a certain kind of thyroid cancer. Actos is approved by the FDA to treat diabetes, but has not been approved yet to treat any cancers.
mCancer Partner: Who can enroll in this clinical trial?
Dr. Koenig: We will enroll adults with a history of follicular thyroid carcinoma or follicular variant of papillary thyroid carcinoma. These people must have metastatic disease or disease that has recurred locally in the neck, and that cannot be cured by further surgery or radioiodine. We will treat them for at least 24 weeks with daily pioglitazone and measure for response using CT scans and blood tests.
mCancer Partner: Where can someone learn more about this clinical trial?
Dr. Koenig: Details, along with contact information for enrolling, are available through UMClinicalStudies. This is a helpful website allowing people to easily search and find clinical and health research studies happening at the U-M. Our study’s ClinicalTrials.gov Identifier is NCT01655719.
Learn more about the Cancer Center’s thyroid cancer program or call the U-M Cancer AnswerLine at 800-865-1125 to speak with a nurse.
Adrenal cancer is extremely rare and challenging to treat. But new research from the University of Michigan Comprehensive Cancer Center shows that the type of surgery you have can make a big difference.
Patients who had an open operation survived twice as long as patients who had laparoscopic surgery, and were less likely to have a recurrence, according to the study, which was published in the journal Surgery.
Barbra S. Miller, M.D.
Barbra Miller, M.D., assistant professor of surgery at U-M, was the lead author on the study. Miller, who specializes in adrenal cancer surgery, talked with mCancer Partner about the study and what it means for patients with adrenal cancer.
mCancer Partner: Did these findings surprise you?
Dr. Miller: Well, there’s been a fair amount of debate over this question. The gold standard for benign adrenal masses is laparoscopic surgery. We like the fact that patients have less pain after this procedure and can go home the next day, so we were hoping we could do it that way for adrenal cancer. But we found that we shouldn’t. Our study showed a real difference in survival, which is critical — and something no one has shown before.
mCancer Partner: Do all patients have surgery for adrenal cancer?
Dr. Miller: Surgery is the mainstay of treatment since there really are no good chemotherapies for adrenal cancer at this time.
Most of the time, when adrenal cancer is found it’s metastatic, and an operation is not helpful. So when we find the disease at a stage when patients can get an operation, you have an opportunity to truly impact their survival — if the operation is done correctly. Continue reading →
Robert Skorupski is a Spartan in Michigan territory and shares his story on how and why he decided to raise money for pancreatic cancer research at the U-M Comprehensive Cancer Center. You can find out more about his and his families journey on his blog or his Facebook page.
My Father-in-Law, Ralph Richard was an incredible man and an integral part of my family. Living only two miles from each other allowed us to spend a great deal of time with our family. Ralph was retired, loved golfing, traveling and cherished spending time with family and friends. Ralph was a pillar of strength in our family, so it was no surprise that from the moment he received the diagnosis, he was determined to fight. Ralph sought advice from multiple doctors and determined his best option was with the University of Michigan Comprehensive Cancer Center…a tough decision living with a family full of Spartans.
The doctors of the Cancer Center worked with Ralph to determine the most aggressive treatment plan possible. The plan involved chemotherapy aimed to stop the potential spread to nearby organs and reduction of the known tumor. Ralph started the chemotherapy treatment right away. After a year, we remained positive because we knew Ralph had already beaten the odds and Ralph was determined to continue do whatever was necessary to spend more time with his family. Ralph willingly participated in clinical trials and other treatments that would hopefully help future pancreatic cancer patients. He not only wanted to get help for himself but he also wanted his experience to help others.
I recall being with Ralph on the chemotherapy floor in UofM hospital. As I sat with Ralph as he received his treatment, I could not help but look up and down the aisle of chemo chairs. There were kids and adults of all races and sizes and it was clear that cancer doesn’t discriminate. There was not an empty chair in the room. His wife Diane stepped away for a cup of coffee and Ralph and I talked about the sports, the grandkids and he reflected on his struggle comprehending his own diagnosis. He said that morning he was called by and old coworker with a family member recently diagnosed with pancreatic cancer. They asked him what to expect, what questions should they ask, what treatments are there to consider? He said it felt good being able to offer help and some type of hope to a terrible situation. After a short pause, he looked at me and said that he often wondered why God picked pancreatic cancer for him and maybe this was the reason… maybe he could help other people and make difference in people’s lives. I smiled and nodded, but deep down wondered if I was ever in that situation, could I be that selfless?
It was that evening sitting in Maize and Blue territory I decided I wanted to do something to help…to try and make a difference…but what? I made a commitment to myself to raise as much money for the Pancreatic Cancer Research Program at UMCCC as possible. This money could help find methods of early detection, prevention and ultimately a cure for this horrible disease. Ok…that what was the easy part…the hard part was the how?
Come back tomorrow for Part 2 on what has been accomplished so far in honor of Ralph.
What goes into researching and developing a cancer drug and what is required for approval by the Food and Drug Administration (FDA)? We sat down with Moshe Talpaz, M.D., Associate Director of translational research at the U-M Comprehensive Cancer Center, for a closer look at the FDA approval process.
Moshe Talpaz, M.D., has been involved in the FDA approval process of many cancer drugs. He leads translational research at the U-M Comprehensive Cancer Center.
Q: What is the general timeframe for a new drug to be approved by the FDA so it is available to patients?
From beginning to end, typical clinical drug development takes around 7-10 years. If a drug is showing remarkable activity and serves an unmet medical need, an accelerated process can go much quicker, maybe around 3 years after the onset of clinical trials.
Q: What is the first part of the process in developing a new drug?
The preclinical process is quite elaborate. Academic medical centers like U-M have the role of discovering what governs a disease, to discover the mutation that drives an illness like cancer. We first focus on the biology to show the full sequence of events in the body. We develop various laboratory approaches to demonstrate that shutting off the abnormal protein kills the cancer cell.
Drug companies then get involved. Medicinal chemists study many different molecules to identify one that has the characteristics of potentially becoming a drug. This becomes the subject for extensive testing on animals to determine that it works safely in the body.
Q: When does research begin with actual patients?
Phase I testing in humans aims to find the maximum tolerated dose. We start with very low doses to check for toxicity. We end up with a safe dose to recommend for use in a Phase II study.
Phase II involves more extensive testing and is where we demonstrate whether the compound is effective and which tumors respond to it.
Phase III is a randomized study of large groups of patients that compares the potential drug to the current standard of care. If the compound reaches a significant goal, which is acceptable to the FDA, the FDA approves it.
Q: What about drugs that go through the accelerated process for FDA approval? Are there disadvantages when drugs go through the process quickly?
I believe the FDA approval process is streamlined and efficient. If a compound proves to be good and there is no question about it, it moves forward quickly in the approval process.
The FDA requires further testing on the drug once patients are using it, and the drug must meet additional milestones later.
Learn more about the clinical trials at the U-M Comprehensive Cancer Center.
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