Patent Application
20080193482
This invention relates generally to the detection and treatment of cancers and auto-immune diseases, and more particularly to a method of screening for and a method of treating duct cell cancer of the breast, squamous cell cancer of the uterine cervix, anal cancer, and auto-immune diseases including diabetes, multiple sclerosis, rheumatoid arthritis metabolic syndrome, lupus, and Acquired Immune Deficiency Syndrome (AIDS).
As is well known, various technologies are available to the medical profession for use in determining the presence of cancers in patients. Included are x-ray studies, magnetic resonance imaging (MRI) studies, CT scans, as well as studies of various body fluids such as blood, urine, etc. Potential sites for colon cancer, for example, can be investigated utilizing electro-optical technologies. In some cases needle biopsy or exploratory surgery is necessary to confirm either the presence or absence of suspected cancer.
Various techniques for treating cancers are also well known. Certain cancers can be surgically removed, whereas other cancers require radiation therapy, chemotherapy, or combinations of radiation therapy and chemotherapy. Other cancers are susceptible to control using one or more drug therapies.
Auto-immune diseases such as diabetes, multiple sclerosis, rheumatoid arthritis metabolic syndrome, lupus, and Acquired immune deficiency syndrome (AIDS) affect persons of all age, race, and gender. Heretofore, treatments available for auto-immune diseases have only been able to control each disease and any corresponding systems. Such treatments vary according to each disease, but typically comprise a combination of a number of medications, testing and diagnostic procedures, and/or various physical therapy treatments. Such treatments and corresponding research focus on cell replacement rather than cell death.
Cell death is generally accepted as a consequence of either a passive, degenerative process called necrosis, or of an active process called apoptosis. Apoptosis may be described as programmed cell death actively driven by the cell. Necrosis is a passive consequence of gross injury to the cell. Causative agents, which initiate cell death cycles, are a group of viruses named recombinant Adeno-Associated viruses (rAA viruses). This family of viruses causes the usual sequence of DNA signals to messenger RNA to reverse itself leading to alteration of immune response in either a positive or negative manner. An over-response leads to an auto-immune disease and an under-response results in rapid proliferation of cells during which the body loses its ability to control cell death, such as in the case of cancer.
The present invention comprises a method of cancer screening, a method of cancer treatment, a method for treatment of diabetes, and a method for treatment of auto-immune diseases which has proven successful in controlling epidermal cancers including, but not limited to, duct cell breast cancer, cervical squamous cancer, and anal cancer, and controlling auto-immune diseases including multiple sclerosis, diabetes, rheumatoid arthritis, metabolic syndrome, lupus, and Acquired Immune Deficiency Syndrome (AIDS). In accordance with the broader aspects of the invention, a method of cancer screening involves a series of testing procedures each more expensive than the one before. Only when results of each of the testing procedures are positive is the presence of cancer confirmed. The invention further comprises a method of treating cancer and insulin dependent Type I diabetes wherein the drug imiquimod is administered transdermally in conjunction with a vaccine that induces production of tumor necrosis factor, for example the BCG vaccine, and valacyclovia hydrochlorine tablets. The method of the present invention treats Type I diabetes by enabling the body to regenerate islet cells. Similarly, multiple sclerosis is managed and treated by enabling the body to repair nerve endings and regenerate damaged fibers.
A more complete understanding of the present invention may be had by reference to the following Detailed Description when taken in connection with the accompanying Drawings, wherein:
The following examples describe a method of detecting and treating duct cell breast cancer, and a method for treating Type I diabetes. However, the present invention is equally applicable to other epidermal cancers, such as squamous cancer of the uterine cervix and anal cancer, and the treatment of and management of auto-immune diseases including multiple sclerosis, rheumatoid arthritis, metabolic syndrome, lupus, and AIDS.
Referring to the Drawings, and particularly to
If the number comprising the results of the Blood CA 27,29 procedure is less than 20, and if there has been no increase in the number comprising the result of the Blood CA 27,29 testing procedure of 5 or more in the immediately preceding year, the result of the Blood CA 27,29 testing procedure is considered to be negative. The patient is then scheduled for follow-up testing utilizing the Blood CA 27,29 procedure in one year.
If the number comprising the result of the Blood CA 27,29 procedure is 30 or above, or if there has been an increase of 5 or more in the number comprising the result of the CA 27,29 testing procedure in the immediately preceding year, the result of the Blood CA 27,29 procedure is considered to be positive. In that event a mammogram testing procedure is administered. If the result of the mammogram testing procedure is negative, an MRI testing procedure is administered. If the result of the MRI testing procedure is negative, both the mammogram testing procedure and the Blood CA 27,29 testing procedure are re-administered in six months time. Conversely, if either the mammogram testing procedure is positive or the MRI testing procedure is positive, a needle biopsy of the identified lesion is performed.
Referring to
If the result of the PET scan testing procedure is negative, the mammogram testing procedure and the Blood CA 27,29 testing procedure are re-administered in six months. If the result of the PET scan testing procedure is positive, a blood tumor cell count testing procedure is administered. If the result of the blood tumor cell count testing procedure is negative, that is, if the number comprising the result of the blood tumor cell count testing procedure is between 0 and 1.5, the blood tumor cell count testing procedure and the Blood CA 27,29 testing procedure are administered at three month intervals. Conversely, if the blood tumor cell count testing procedure is positive, that is, if the number comprising the result of the blood tumor cell count testing procedure is two or above, the cancer treatment procedure of the present invention is administered.
The cancer treatment procedure of the present invention comprises the transdermal administration of the drug imiquimod combined with a vaccine that induces production of tumor necrosis factor and administration of valacyclovia hydrochlorine tablets. Imiquimod is commercially available from 3M Pharmaceuticals under the trademark ALDARA® (imiquimod). A healthy human body produces the protein interferon alpha in response to an infection. Interferon alpha works to coat the infection or virus in order to make the infection or virus vulnerable to the human immune system. Imiquimod cream induces the production of interferon alpha once inside the human body, providing the needed interferon alpha not adequately produced by the patient's own body. In accordance with the present invention, ALDARA® (imiquimod) cream 5% is mixed at a 1:1 ratio with H base cream. The ingredients of H base cream are:
The mixture of imiquimod and H base cream as described above is administered transdermally, preferably by mixing ¼ cc ALOARA® (imiquimod) 5% cream with ¼ cc H base cream and applying the resulting mixture to various locations, i.e., the inner thigh, abdomen, hip, arms, etc., of the patient. Various sites of administration prevent any possible skin irritation. The foregoing amount of the mixture of ALDARA® (imiquimod) 5% cream and H base cream is applied daily.
Tumor necrosis factor (also called TNFa, cachexin, or cachetin) stimulates T-cells that coordinate the immune system. In a healthy human body, tumor necrosis factor is released by white blood cells and other tissues in response to damage caused by an infection. Tumor necrosis factor is found in several vaccines. The preferable vaccine to be used in accordance with the present invention is the BCG vaccine, which is a common vaccine for tuberculosis, given in the United States and around the world. The tumor necrosis factor produced by the BCG vaccine and imiquimod cream work together to stimulate the T-cells and coordinate and improve the patient's immune system. Interferon alpha coats the virus or infection in order to make the virus or infection vulnerable to the tumor necrosis factor.
In accordance with the present invention, the vaccine is given in doses of 0.1 mL (100 μg) once every three weeks as long as the treatment continues. Valacyclovia hydrochlorine tablets, available from GlaxoSmithKline under the trademark VALTREX® (valacyclovir), is a drug commonly used in the treatment for genital herpes. In accordance with the present invention, VALTREX® (valacyclovir) tablets are consumed twice daily in 500 mg doses. The combination of the ALDARA® (imiquimod) and H base cream, the BCG vaccination, and the VALTREX® (valacyclovir) tablets is administered until a blood tumor cell count indicates that there are no cancer cells in the blood and a subsequent blood tumor cell count verifies a normal cell count and no mestastases are present. The results of the procedure are periodically monitored utilizing the Blood CA 27,29 testing procedure.
Referring to
The diabetes treatment procedure of the present invention comprises the transdermal administration of the drug imiquimod combined with a BCG vaccination and administration of valacyclovia hydrochlorine tablets. Imiquimod is commercially available from 3M Pharmaceuticals under the trademark ALDARA® (imiquimod). A healthy human body produces the protein interferon alpha in response to an infection. Interferon alpha works to coat the infection or virus in order to make the infection or virus vulnerable to the human immune system. Imiquimod cream induces the production of interferon alpha once inside the human body, providing the needed interferon alpha not adequately produced by the patient's own body.
In accordance with the present invention, ALDARA® (imiquimod) cream 5% is mixed at a 1:1 ratio with H base cream. The ingredients of H base cream are:
The mixture of imiquimod and H base cream as described above is administered transdermally, preferably by mixing ¼ cc ALDARA® (imiquimod) 5% cream with ¼ cc H base cream and applying the resulting mixture to various locations, i.e., the inner thigh, abdomen, hip, arms, etc., of the patient. Various sites of administration prevent any possible skin irritation. The foregoing amount of the mixture of ALDARA® (imiquimod) 5% cream and H base cream is applied daily.
The results of the procedure are monitored utilizing blood sugar meters and a diary to record ongoing blood sugar levels. Additionally, A-1-C checks track the patient's overall blood sugar levels over two to three month periods, and is the most effective way to track long-range success of the treatment. The treatment method regenerates islet cells, which produce insulin. Once the patient no longer depends on insulin to correct blood sugar levels, the treatment continues until the patient has two or more sequential A-1-C checks in the target range, depending on the judgment of the treating physician. Once treatment is discontinued, A-1-C checks continue, but at less frequent intervals as recommended by the treating physician.
Referring to
If the number comprising the result of the Blood CA 27,29 procedure is 30 or above, or if there has been an increase of 5 or more in the number comprising the result of the CA 27,29 testing procedure in the immediately preceding year, the result of the Blood CA 27,29 procedure is considered to be positive. In that event the patient begins medicinal treatment selected from one or more of the following medications and treatments: 1) oral administration of one tablet of about 10 mg to about 20 mg per day of ACOMPLIA™ (rimonabant), a Cannabinoid receptor type 1 (CB1) blocker; 2) Oral administration of calcitriol or 1,25-dihydroxycholecalciferol, which is the active form of vitamin D3 found in the body, taken in capsules of about 400 IU to about 800 IU once or twice daily; 3) administration of a RECOMBIVAX HB® (recombinant) Hepatitis B vaccine, administered once per month for three months followed by a booster vaccine six months after the final vaccine, each dose comprising about ¾ cc to about 1 cc; 4) following a low protein diet; 5) maintaining a directed exercise plan; 6) topical administration of about ¾ cc to about 1¼ cc daily of a cream mixture comprising ALDARA® (imiquimod) 5% cream and either H base cream or Q base cream as described herein in conjunction with
After a course of the patient's treatment as directed by the patient's doctor, a biopsy is performed on one or more suspicious tissue samples taken from the patient, either a needle biopsy of a tissue sample or an excisional biopsy of an entire lump or suspicious area, determined according the patient's individual prognosis. If the results of the biopsy is positive, the patient is given a series of RECOMBIVAX HB® (recombinant) Hepatitis 2 vaccines. Upon completion of treatment with RECOMBIVAX HB® (recombinant) positron emission tomography (PET) and/or computed axial tomography (CAT) scans are performed on as much of the patient's entire body as possible according to the patient's medical history and condition. If the results of the PET or CAT scans are positive the patient resumes the treatment plan comprising one or more of the above enumerated treatments and medications.
Referring now to
(1) Topical administration of a about ¾ to 1 cc of about 50 mg DHEA sulfate cream. The DHEA sulfate cream is prepared by mixing a cream form of a hormone dehydroepiandrosterone (DHEA) with a commercially available non-steroid cream, the mixture resulting in a non-anabolic steroid cream which is applied topically for the purpose of attracting and activating killer-T Lymphocytes in order to treat cancer. A primary carrying agent for DHEA is a proprietary compound, Q-base cream. Q-base cream is available to compound pharmacies all over the United States and consists of the following formulation:
The ratio of ingredients comprising the Q-base cream/DHEA mixture is between about 25 mg and about 50 mg of DHEA to about 1 cc of Q-base cream.
Alternatively, the carrying agent for the DHEA may comprise H-base cream. The formula for H-base cream is as follows:
The ratio of ingredients comprising the H-base cream/DHEA mixture is between about 25 mg and about 50 mg of DHEA to about 1 cc of H-base cream.
The DHEA cream mixture in either the Q-base cream/DHEA mixture or H-base cream/DHEA mixture is combined with a cream comprising sulfate, preferably chondroitin sulfate and/or glucosamine sulfate. One such commercially available cream is a deep tissue massage lotion produced by Lasting Touch™, “Lasting Touch Deep Tissue Therapy Massage Lotion.” In accordance with the present invention, the DHEA cream mixture, either Q-base or H-base, is mixed with the cream comprising sulfate at a 1:1 resulting in a DHEA sulfate cream for topical application;
(2) Administration of a BCG vaccine containing tumor necrosis factor (also called TNFa, cachexin, or cachetin) which stimulates T-cells that coordinate the immune system;
(3) Oral administration of about 400 IU to about 800 IU capsules once or twice daily of calcitriol or 1,25-dihydroxycholecalciferol, which is the active form of vitamin D3 found in the body. Vitamin D3 aids the body in absorption of calcium and phosphate from the kidneys and gastrointestinal tract;
(4) Oral administration of Omega 3 Fatty acids which have several enumerated health benefits, including, but not limited to increased blood circulation, reduction in blood triglyceride levels, protective effects against cardiovascular disease, and many other benefits well known to those skilled in the medical field. The preferable brand and dosage of Omega 3 fatty acids is Lovaza® brand fish oil pills, three to four 1 g capsule taken two times per day;
(5) Once daily oral administration of about 10 mg to about 20 mg of ACOMPLIA™ (rimonabant), a Cannabinoid receptor type 1 (CB1) blocker, taken once daily;
(6) Oral administration of a tablet of about 500 mg to about 1,000 mg of NIASPAN™ (niacin), an extended release form of niacin available from Abbot Laboratories®, which blocks the breakdown of fats and alters blood lipid levels. The NIASPAN™ (niacin) tablet is taken once daily at or near bedtime. If symptoms such as severe flushing and/or itching occur, the patient may also take a pain reliever such as acetaminophen and an antihistamine such as diphenhydramine in conjunction with the NIASPAN™ (niacin) tablet;
(7) Following a low protein, plant-based diet;
(8) Maintaining a directed exercise plan;
(9) Administration of a ¾ cc to about 1 cc RECOMBIVAX HB® (recombinant) Hepatitis B vaccine, administered once a month for three consecutive months and followed by a booster vaccine six months after the third consecutive vaccine; and
(10) Following a triple therapy treatment comprising a) FLAGYL® (metronidazole), a drug administered primarily for the treatment of infections caused by susceptible organisms, the FLAGYL® (metronidazole) administered both by topical administration of a cream and/or oral administration of one half to one of an about 250 mg to about 500 mg tablet twice daily, b) oral administration of one about 400 mg tablet of AVELOX® (moxifloxacin) taken once daily, a drug primarily used in the treatment of respiratory infections, and c) oral administration of one 20 mg to 40 mg tablet of NEXIUM® (Esomeprazole) once daily, a proton pump inhibitor used to reduce gastric acid secretions and also used in treatment combinations for Helicobacter pylori infections. The selection of, dosage, and frequency of any selected treatment is determined and adjusted by the patient's doctor according to the patient's body. The triple therapy comprising a combination of FLAGYL® (metronidazole), NEXIUM® (esomeprazole), and AVELOX® (moxifloxacin) may be administered beginning one month after starting the combination of treatments selected by the doctor and may be continued for two weeks thereafter.
The patient is thereafter re-tested periodically according to traditional cancer screening and diagnostic testing methods well known to those skilled in the medical field, including the blood CA 27,29 test mentioned hereinabove. Further treatment is directed as needed according to the outcome of the periodic testing. As the patient's symptoms and test results improve, testing may be performed at less frequent intervals such as yearly or bi-yearly to monitor the patient's continued health status.
Referring now to
The patient is thereafter tested periodically according to traditional screening and testing methods for each individual auto-immune disease well known to those skilled in the medical field. Further treatment is directed as needed according to the outcome of the periodic testing. As the patient's symptoms and test results improve, testing may be performed at less frequent intervals such as yearly or bi-yearly to monitor the patient's continued health and verify the disease is maintained or remains in remission.
Although preferred embodiments of the invention have been illustrated in the accompanying Drawings and described in the foregoing Detailed Description, it will be understood that the invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications, and substitutions of parts and elements without departing from the spirit of the invention.
This application is a continuation-in-part application of application Ser. No. 11/533,805 filed Sep. 21, 2006, currently pending, the entire contents of which are incorporated herein by reference; which is a continuation application of application Ser. No. 11/133,838 filed May 19, 2005, now U.S. Pat. No. 7,125,836, the entire contents of which are incorporated herein by reference; which is a divisional of application Ser. No. 11/032,399 filed Jan. 10, 2005, abandoned, the entire contents of which are incorporated herein by reference; which is a continuation-in-part application of application Ser. No. 11/003,293 filed Dec. 3, 2004, currently pending, the entire contents of which are incorporated herein by reference; which is a continuation-in-part application of application Ser. No. 10/946,213 filed Sep. 21, 2004, currently pending, the entire contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11032399 | Jan 2005 | US |
| Child | 11133838 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11133838 | May 2005 | US |
| Child | 11533805 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11533805 | Sep 2006 | US |
| Child | 12100089 | US | |
| Parent | 11003293 | Dec 2004 | US |
| Child | 11032399 | US | |
| Parent | 10946213 | Sep 2004 | US |
| Child | 11003293 | US |
