To some he was a son, others a brother and a friend. He never got to be a father or the world’s greatest uncle, but he left this world with people always remembering the name Michael James Fox. In was the winter of 1973, a three-year-old boy was diagnosed with ALL.
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All this little boy wanted was to live his life to its fullest potential, even though everyday was a struggle for him. At the end of his rough eighteen years he lost his ability to walk as the cancer began to deteriorate his body even more. He went through 15 years of tests and treatments that ultimately did not work. He struggled through life for eighteen years, but he always had a smile on his face. Doctors told his family that it was a miracle that he lived as long as he did. He was a strong and brave little boy who accepted his pain and never complained. He loved everyone, and everyone loved him. He left an impact on every heart he touched. He tried like crazy to overcome this disease and be out of pain. This essay with analyze issues related to leukemia immunotherapy clinical trials. It will focus on the following three areas of discourse: Qualifications, Sides affects, and the effectiveness compared to chemotherapy.
Leukemia is a type of cancer that starts in cells that normally develop into different types of blood cells, as stated by the American Cancer Society. There are many different forms of leukemia from acute or fast growing to chronic or slower growing. Acute Lymphocytic Leukemia also known as Acute Lymphoblastic Leukemia is a fast-growing form of Leukemia. ALL starts in the bone marrow and the cancerous cells tend to invade the blood stream very quickly. The cancer develops form immature forms of white blood cells known as lymphocytes. All would be fatal in the first few months of not treated. Many years ago, children being treated for ALL did not live very long. Except for a few cases where the children got to live longer, but everyday was a struggle. However, with improvements in technology and new scientific developments happening all the time most children with ALL go into remission. When a cancer patient is in remission for so long they are considered cured. There are new drug trials that are making the high number of remission cases possible.
Chemotherapy is starting to make its way out of cancer treatments. Doctors are moving into a more direct and effective way of treating cancer. Clinical trials for immunotherapy can be completed in four phases according to the Leukemia and Lymphoma Society. When each phase becomes successful the trial then moves onto the next phase. Phase one starts with a small test group to test the safety of the new drug. During this phase is also when the correct dosage and the best way to administer the drug is determined. There are many ways to administer the drug. The five most common are Intravenously through an IV or catheter, Intramuscular where the drug is injected directly into the arm, thigh, or buttock, Oral via a pill, capsule, or liquid, Subcutaneous injections which the drug is injected into the tissue under the skin, and lastly Intrathecal therapy where the drug is injected directly into the spinal cord via lumbar puncture. Once phase one is complete and the drug is proven safe then the trial can move onto phase two. Phase two is conducted on a larger test group to determine the drugs effectiveness. If the drug is not proven to be effective, then the scientists must go back to the drawing board and start over. If the drug is proven effective, then the trial can move onto the third phase. Phase three is when the doctors put together a treatment group and a controlled group to compare the results. As phase three is coming to an end and phase four is beginning the FDA usually approves the drug for use instead of chemotherapy. Phase four is primarily used for determining if the drug can be used as a treatment for anything else (How a clinical trial works). The length of time for each phase varies on the test group and the drug being used in the trial. The American Cancer society states that treatment usually lasts for about two years and the first couple months are often very intense (Treating Acute Lymphoblastic Leukemia (ALL)).
Taking part in clinical trials requires specific qualifications. If one does not meet all the qualifications it is up to the doctor to make the final call if a trial is possible. According to the Leukemia and Lymphoma Society “Your eligibility for any given clinical trial depends on many factors, especially your disease type and stage, your age, gender and race, and other treatments you’ve used” (Clinical Trials). Some patients may have already begun the treatment process and the medications they were previously may or may not interfere with the new drug. So, they either must wait for the drug to clear their system or they will be denied from the trial and they will have to wait to see if they qualify for a different trial.
There was a study conducted at the Children’s hospital of Philadelphia and it was found that 92% of the thirty-nine children with relapsed, refectory ALL that participated in the immunotherapy trial ended with complete remission (Azvolinsky). These thirty-nine children met the requirements of being a child, going into remission and then relapsing, and having a specific type of ALL. With having childhood cancer, the children not only have to meet very strict requirements they also must get their parents to sign off. Some parents are skeptical of the new trials because they have not yet proven to be effective.
Some adults would like to participate in the trials but if they don’t meet the criteria and their doctor does not approve them, they cannot participate in the trial. The qualifications for each trial are different but they all have most of the underlying requirements in common. Most older patients have already started chemotherapy and that could influence certain trials. “Clinical trials cover a wide range of research and are designed with specific requirements that determine who is eligible to participate. For instance, researchers may be specifically looking for patients who: have already tried standard treatment, have not had any previous treatment, have had standard treatment and are able to wait for a period before switching to a study treatment, do not have co-existing medical conditions such as liver or kidney disease” (Clinical Trials). Once a patient gets approved for a trail, they then must deal with the side effects of the treatment.
Immunotherapy targets a patient’s immune system making them more susceptible to infections. One type of immunotherapy treatment is monoclonal antibody treatment. The Leukemia and Lymphoma Society tells us that, this type of treatment is given in an outpatient setting through an IV and is typically a couple weeks long. Typically the most common side effects include fever, chills, headache, tiredness, and nausea. Shortness of breath, a drop-in blood pressure, an irregular heartbeat, chest pain, and low blood cell counts are some of the more severe and less common side effects to Rituxan and Campath (Immunotherapy). Some of these side effects can become life threatening. Occasionally the doctor will give one medication to prevent certain side effects.
Another type of immunotherapy used to treat mainly leukemia and lymphomas is Radioimmunotherapy. “Occasionally, patients have a severe allergic reaction to the infusion… Fever, chills, and aches can occur after treatment… some patients have mild to moderate reactions that tend to be short lived. These include: low blood pressure, diarrhea, and a rash or swelling at the injection site” (Immunotherapy). Different people react differently to each treatment. If one has had previous treatment, that could make certain side effects more prominent than others or they could have no side effects at all. Doctors monitor all side effects that one has and may decide to stop the trial because it is hurting the patient instead of helping them or they will continue treatment, but make sure to keep the more severe side effects under control.
Immunotherapy has proven itself to be effective, so people who meet the qualifications are opting for immunotherapy instead of chemotherapy. Immunotherapy has its side effects and chemotherapy has its own side effects, therefore the side effects of each treatment would not be one of the deciding factors on which treatment option is the best fit. According to, Naval G. Daver, MD, associate professor, Department of Leukemia at The University of Texas MD Anderson Cancer Center, “The trial shows you two things: 1) how bad chemotherapy does in the salvage population, and 2) this drug is much more effective… If you look at the tail of the curve, at two as well as three years, you are getting 15% to 20% more patients alive at those marks, which I think is important because it shows a durability component beyond the median” (Hitchcock). Daver is explaining that immunotherapy is surpassing chemotherapy in terms of effectiveness in remission cases.
If given the option to take part in an immunotherapy trial, most patients are opting to participate, given the recent success. In articles from the Leukemia and Lymphoma Society on Immunotherapy and Chemotherapy patients are given a very detailed description of what each treatment option offers and entails. Immunotherapy can be used several different ways, including: combination with other types of cancer treatment, as maintenance therapy after combination chemotherapy, or as a single agent. Immunotherapy has many different strains used to treat specific types of blood cancer and many more are still being studied and/or tested. There are currently three general approaches to treating with Immunotherapy (Immunotherapy). While Immunotherapy looks appealing to most people, not everyone qualifies so they must continue or start chemotherapy.
Chemotherapy has been around as a cancer treatment for a very long time. However, with new scientific advancements in cancer research it is very rapidly dying out as a treatment option. The article on Chemotherapy from the Leukemia and Lymphoma Society discusses the upsides and downsides of chemotherapy. Chemotherapy is a very limited multi-step treatment option, that requires potent drugs or chemicals. It is found that most of the time patients that have gone through chemotherapy need pot-remission treatment. Over the past forty years cancer survival has become more common due to advances in chemotherapy. The one major downside of chemotherapy is that if the cancer is not diagnosed 100% accurate the drugs will not work properly and could kill healthy cells instead of the cancerous cells (Chemotherapy). Both chemotherapy and immunotherapy are great treat treatment options, in their own ways, it is ultimately up to the patient and the doctor to determine what treatment option is the best fit for that cancer case.
In conclusion, that little boy that just wanted to live his life and be a normal teenager never got the chance because developments in cancer research were not where they are today. His younger sister was only fourteen years old when she lost her older brother, but she still gets to see him every day, as certain character traits that he had appear in her own children. If only he could have gotten today’s treatment when he got sick, he would have gotten to see how much his niece and nephew are just like him. Michael James Fox will always have a special spot in everyone’s heart. Where he grew up, childhood cancer was a very uncommon thing, so still to this day people remember him and what went through. All the tests and treatments were not successful, and heaven gained another soul in 1988.
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