Authors: Connie Strasheim
At our clinic, we have antineoplastic medications that address all of these areas. Nevertheless, every one of our patients is different, and because cancer can alter its DNA, we are always working with a moving target. Currently, scientists have discovered that there can be up to 3,152 different abnormal genes in cancer, and that count will increase over the next year or two as they continue to discover new genes. My average patient has approximately 80 of these, so
there are a tremendous number of abnormal gene combinations which can result in a patient. Since every patient has a unique genomic signature, we can’t use the same treatment for everybody.
It’s important to emphasize that although patients may be diagnosed with the same type of cancer, the abnormal genes which cause their cancers will be different. We have to identify the particular genetic signature of each one of our patients and then put together the best combination of medications that will neutralize their cancer-causing genes.
Before new patients come to our clinic, we review their medical records to make sure that we can treat them. Many people come here from other states and countries and we don’t want them to travel long distances if we are unable to help them. That’s the first step in our assessment process. Then we do an initial consultation, and after that, we’re usually able to start them on a treatment regimen. We also collaborate with their local doctors, since they will ultimately do most of our treatments at home. After they have been on a regimen for two or three months, we may then ask them to come back to the clinic for a day so we can make any necessary adjustments to their treatment plans. We try to get their oncologists to cooperate with us, so they can also work together with them on this.
Our initial consultation involves testing the cancer cells in the blood, the results of which enable us to determine the activity of our patients’ most important oncogenes. We are usually able to get the information we need from these tests in just two days, and can begin treatments soon thereafter. In some cases, though, we need to revise patients’ treatments after further testing of their specimens.
Doing a tumor biopsy is a good way to get a sample of a patient’s cancer cells, but it takes a few weeks to get biopsy results back. I would prefer to do biopsies over blood tests, but they aren’t practical because most of our patients need treatment right away. In any
case, blood tests can sometimes be more useful than biopsies, because in metastatic cancer, every tumor in the body has a different genome. Taking a sample from one tumor won’t necessarily tell us what’s going on in the rest of the body and how to treat the other tumors.
Eventually though, we try to take a biopsy of the entire cancerous genome in all of our patients and we conduct tests of the proteins that are produced by the most important oncogenes found in their blood. Both the patient and the patient’s cancer must be properly profiled at the molecular level in order to specifically identify the genes and characteristics that are causing the cancer to grow.
The most sophisticated methods of gene testing involve isolating actual cancer cells from the blood instead of just studying the products of the oncogenes within the patient’s blood sample. We aren’t using this technology yet, but are likely to adopt it in the near future because it would allow us to test not only mature cancer cells, but also malignant stem cells, which have a different genome than the mature cells. So for the time being, we take a regular blood sample, test cancerous tissue (do a biopsy), and then test for genetic compatibility between the patient’s oncogenes and our antineoplastic medications. Then we prescribe medications that we know will kill the malignant cells which carry these oncogenes.
The accurate selection of gene-targeted medications depends upon all of the following: knowledge of which medications were proven in clinical trials to work on specific cancers, results of the patient’s cancer genome analysis from tissue and blood tests, knowledge of what the patient’s chief cancerous genes are, access to up-to-date clinical trial algorithms for comparison and disease matching, and properly evaluating the patient in order to determine the correct disease-stage diagnosis. Our clinic is currently working on a computer program which will automatically perform these required tasks. We anticipate that this new software will be ready in March 2011. Our database is updated daily and information from our database will be utilized by the new program.
As previously mentioned, we use a combination of medications that will target approximately 100-200 of the patient’s genes: medications that will turn off the abnormal genes that promote cancer, while also turning on the normal genes that protect against cancer. These medications are usually sufficient to get rid of the tumors in about 80 percent of our patients. These are people who were told by conventional oncologists that nothing else could be done for them. For the remaining 20 percent of our patients, the treatment doesn’t work and we have to do a genetic analysis again to try to come up with a different combination of medications for them. Sometimes, our treatments don’t work because cancers continuously mutate and two months down the road, a cancer genome may look completely different than when the patient was first tested.
Determining patients’ genetic signatures and designing an appropriate treatment regimen for them takes a lot of experience and practice. We must find medications which work well together and do not counteract one another. If doctors who perform gene targeted therapy take the wrong approach, they can cause their patients’ cancers to spread faster. Therefore, it’s important they understand cancer genetics. This skill can be learned. We have found that if we treat our patients properly, then they don’t suffer adverse reactions, their tumors disappear, and their cancers don’t come back. If done correctly, cancer treatment should be effective, without producing adverse reactions in the body.
Currently, we use three different preparations of antineoplastons at our clinic, one of which has been approved by the FDA, and two of which are in the process of being approved. Two antineoplastons are administered intravenously (IV), and one is taken orally. The oral antineoplaston is called phenylbutyrate and the two IV antineoplastons are called Antineoplaston A10 and AS2-1.
While the oral antineoplaston is FDA-approved for use in general practice, intravenously administered antineoplastons are approved
only for use in clinical trials, so we tend to use the oral drugs more often, since we have more flexibility with them.
In addition to antineoplastons, we also give our patients other gene-targeted medications that have been approved by the FDA. These are different from antineoplastons because they work on different and smaller groups of genes than antineoplastons (generally only one to fourteen genes, compared to antineoplastons, which may work on as many as one hundred genes).
When prescribing a regimen for the majority of our patients, we combine phenylbutyrate with other gene-targeted medications, which we select based on the results of our patients’ genomic analyses. Our approach is to treat the combination of genes that are causing cancer. When prescribing medications, we also consider the type of cancer that patients have, but this is secondary to the gene analysis.
In practice, phenylbutyrate, when dosed orally, affects a smaller number of genes than IV antineoplastons because the dosing of oral medications is markedly lower than what patients would receive via intravenous administration. We need to affect 50-200 of our patients’ genes, so we give them multiple medications to accomplish this. A woman with breast cancer, for example, requires treatment for at least 60 of her genes. Oral phenylbutyrate would affect only 43 of these, so we would add other gene-targeted medications to her regimen, such as lapatinib (which works on two genes), trastuzumab (which works on only one gene) and sorafenib (which works on fourteen genes).
Of these medications, only lapatinib and trastuzumab have been approved by the FDA for the treatment of breast cancer. Sorafenib is currently approved for kidney, pancreatic, and liver cancers (but sometime during the next two years, it will probably also be approved for breast cancer). Still, we may choose to use phenylbutyrate and sorafenib “off label” to treat breast cancer, because the patient’s genomic analyses might reveal them to be the most effective medications for this type of cancer. The majority of
gene-targeted medications only work on a single or small number of genes.
In the end, our patients might take anywhere from three to five different medications, but the combination that we prescribe is different for everyone because the genetic signature of each person’s cancer is different.
For the rest of our patients, the minority, we use the intravenous antineoplastons, which affect 94 genes and have only been approved for use in clinical trials. While use of these agents is more tightly regulated, we are able to give them to patients who have consented to participate in these trials. Typically, we administer both of our IV antineoplastons (Antineoplaston A10 and AS2-1) to patients concurrently, without adding any additional oral anti-cancer medications to their regimens, because the FDA doesn’t permit us to use them in conjunction with IV therapies. This is unfortunate because clinical trials on patients undergoing anti-neoplaston therapy in Japan have demonstrated that a combination of intravenous and oral antineoplastons is the most effective treatment strategy.
In an ideal world, we would use intravenous antineoplastons on all of our patients, in addition to oral gene-targeted medications, because combining two intravenous antineoplastons with additional gene-targeted agents would affect approximately 200 genes. However, we aren’t allowed to do this due to FDA regulations, so we work within our operating limitations and make the best of our resources.
We evaluate our patients throughout the course of their treatment by monitoring their physical condition, measuring the size of their tumors, and checking their different tumor markers, which indicate tumor activity. If we have chosen the right medications, we usually see a substantial decrease in the size of their tumors within two months, so we would then continue with those medications until their tumors are gone. Most people’s tumors are completely gone
within four to six months. (Although our patients only stay at our clinic for two weeks, they continue to take the medications at home while following up with their oncologists). After four to six months, we usually find no trace of cancer in their lungs, liver, or anywhere. We have even seen some tumors disappear within three to four weeks if we find the right molecular switches. When the tumor disappears and we can’t find cancer anywhere in the body, we assume that the patient has had a complete response to our treatments. We then switch them to a maintenance regimen for an additional eight to twelve months to prevent their cancers from coming back, and that’s the end of the story. We have patients who have been cancer free for over twenty years.
In the majority of our patients we see very good results using this approach. Oncologists can also administer this type of therapy, because there are now close to 40 different gene-targeted medications available in pharmacies which work on cancer genes. Over the next three years, it’s estimated that there will be at least one hundred different medications available. If oncologists learn the proper use of such medications, they could save the lives of many more of their patients.
The antineoplaston medications that we use in our clinic can also resolve numerous other problems in the body, which means that they can heal other diseases, such as Multiple Sclerosis and Lupus. We have conducted brief clinical trials on the use of antineoplastons for different autoimmune diseases and have had some interesting results. But right now, our focus remains upon using them for cancer treatment. At some point, we may expand our work into other areas of medicine.
Many of our patients have been “wasted” by their cancers and previous treatments, so we have two expert nutritionists at our clinic who provide dietary and supplement recommendations to
help them build up their bodies. We design intravenous nutritional protocols for some people, which they follow at the beginning of their treatments. We also design individual diets for each of our patients, because what’s good for one patient isn’t necessarily good for another. The specific medications they take, for example, are an important consideration when determining their dietary regimens, because medications and supplements may interact with one another.
We have also developed a line of nutritional supplements that support our antineoplaston treatments, called Aminocare (
www.aminocare.com
), which can reduce the side effects of medications and improve normal body functioning. These products support the immune system, increase the body’s energy, protect it against toxic insults, and aid in the regulation of normal cell division.
Regardless of its initial causes, cancer ultimately results from a change in the genes. Treatments that target the genes eliminate cancer, as opposed to treatments that destroy the cancer and also the body. Fortunately, some nutritional supplements can also regulate gene expression and people who are vulnerable to cancer may be able to regulate the expression of their genes by using these alone and thus may not even require medication. In the future, I believe that there will be easy methods for determining whether patients have abnormalities in their genes that could lead to cancer. Then doctors will be able to make specific dietary and supplement recommendations which will restore their patients’ genes to normalcy and prevent them from getting cancer.
Some of the supplements that we recommend for cancer prevention include AminoCare A10 and AminoCare Brain Longevity, which are amino acid derivatives (small molecular peptide) gel capsules that are designed to reduce the deterioration of brain function that results from the aging process. We recommend that everyone who has reached a certain age take both of these as a preventative
measure against cancer. We prescribe an easy regimen that consists of taking only a few capsules per day. We also have an after-sun lotion and cosmetic cream which protect against skin damage. The company Healthy Directions distributes all of these supplements.