U.S. patent application number 11/032399 was filed with the patent office on 2006-03-23 for method of cancer screening; method of cancer treatment; and method of diabetes treatment.
Invention is credited to John R. Woodward.
Application Number | 20060062755 11/032399 |
Document ID | / |
Family ID | 36074247 |
Filed Date | 2006-03-23 |
United States Patent
Application |
20060062755 |
Kind Code |
A1 |
Woodward; John R. |
March 23, 2006 |
Method of cancer screening; method of cancer treatment; and method
of diabetes treatment
Abstract
A method of cancer screening comprising the steps of
administering the Blood CA 27,29 testing procedure; if the result
is positive administering a mammogram; if the result is positive
administering an needle biopsy; if the result is positive
administering a PET scan; if the result is positive administering a
blood tumor cell count. If all of the foregoing steps are positive,
the cancer is treated by applying imiquimod transdermally to
rotating sites, preferably by mixing ALDARA.RTM. (imiquimod) 5%
cream with an equal amount of H base cream; administering a vaccine
containing tumor necrosis factor, preferably the BCG vaccine; and
orally administering VALTREX.RTM. (valacyclovir) twice daily. The
foregoing treatment method is also effective in treating Type I
diabetes, MS, and other epidermal cancers.
Inventors: |
Woodward; John R.; (Dallas,
TX) |
Correspondence
Address: |
MICHAEL A. O'NEIL, P.C.
5949 SHERRY LANE, SUITE 820
DALLAS
TX
75225
US
|
Family ID: |
36074247 |
Appl. No.: |
11/032399 |
Filed: |
January 10, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11003293 |
Dec 3, 2004 |
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11032399 |
Jan 10, 2005 |
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10946213 |
Sep 21, 2004 |
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11003293 |
Dec 3, 2004 |
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Current U.S.
Class: |
424/85.1 ;
435/7.21; 514/263.32; 514/291 |
Current CPC
Class: |
A61K 31/522 20130101;
A61K 39/0008 20130101; A61K 38/191 20130101; A61K 31/4745 20130101;
A61K 31/4745 20130101; A61K 2300/00 20130101; A61K 31/522 20130101;
A61K 2300/00 20130101; A61K 38/191 20130101; A61K 2300/00 20130101;
A61K 39/0008 20130101; A61K 2300/00 20130101; A61K 39/0011
20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/085.1 ;
435/007.21; 514/263.32; 514/291 |
International
Class: |
G01N 33/567 20060101
G01N033/567; A61K 31/522 20060101 A61K031/522; A61K 38/19 20060101
A61K038/19; A61K 31/4745 20060101 A61K031/4745 |
Claims
1. A method of cancer screening and cancer treatment comprising the
steps of: administering the Blood CA 27,29 testing procedure and
thereby determining the presence of a predetermined cancer; and the
subsequent step of treating the cancer identified by the preceding
step by concurrent transdermal administration of imiquimod,
injection of a vaccine containing tumor necrosis factor, and oral
administration of valacyclovir.
2. The method of cancer screening according to claim 1 wherein the
step transdermally administering imiquimod is carried out by mixing
1/4 cc of ALDARA.RTM.(imiquimod) 5% cream with 1/4 cc H base cream
(i) and transdermally administering the resulting mixture.
3. A method of treating duct cell breast cancer comprising the
steps of: providing a quantity of ALDARA.TM. 5% cream; providing a
quantity of H base cream.TM.; mixing 1/4 cc. of the ALDARA.TM. 5%
cream with 1/4 cc. of the H base cream.TM. and transdermally
administering the resulting mixture to the patient; administering a
vaccine containing tumor necrosis factor; and orally administering
Valtrex.TM. tablets.
4. The method of treating duct cell breast cancer according to
claim 3 wherein the ALDARA.TM. 5% creamtH base cream mixture is
applied daily and the progress of the procedure is monitored using
the Blood CA 27,29 testing procedure.
5. The method of treating duct cell breast cancer according to
claim 3 wherein the vaccine containing tumor necrosis factor is
administered every three weeks and 500 mg Valtrex.TM. tablets are
orally administered twice daily.
6. The method of treating duct cell breast cancer according to
claim 5 wherein the progress of the procedure is monitored using
the Blood CA 27,29 testing procedure.
7. A method of treating Type I diabetes comprising the steps of:
providing a quantity of ALDARA.TM. 5% cream; providing a quantity
of H base cream.TM.; mixing 1/4 cc. of the ALDARA.TM. 5% cream with
1/4 cc. of the H base cream.TM. and transdermally administering the
resulting mixture to the patient; administering a vaccine
containing tumor necrosis factor; and orally administering
Valtrex.TM. tablets.
8. The method of treating Type I diabetes according to claim 7
wherein the ALDARA.TM. 5% cream/H base cream mixture is applied
daily, the vaccine containing tumor necrosis factor is administered
every three weeks and 500 mg Valtrex GM) tablets are orally
administered twice daily.
9. A method of treating multiple sclerosis comprising the steps of:
providing a quantity of ALDARA.TM. 5% cream; providing a quantity
of H base cream.TM.; mixing 1/4 cc. of the ALDARA.TM. 5% cream with
1/4 cc. of the H base cream.TM. and transdermally administering the
resulting mixture to the patient; administering a vaccine
containing tumor necrosis factor; and orally administering
Valtrex.TM. tablets.
10. The method of treating multiple sclerosis according to claim 9
wherein the ALDARA.TM. 5% cream/H base cream mixture is applied
daily, the vaccine containing tumor necrosis factor is administered
every three weeks and 500 mg Valtrex.TM. tablets are orally
administered twice daily.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of
application Ser. No. ______ filed Dec. 3, 2004 (our file
120175-1005), currently pending, which is a which is
continuation-in-part application of application Ser. No. 10/946,213
filed Sep. 21, 2004, currently pending.
TECHNICAL FIELD
[0002] This invention relates generally to the detection and
treatment of cancers, 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,
diabetes, and multiple sclerosis.
BACKGROUND AND SUMMARY OF THE INVENTION
[0003] 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.
[0004] 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.
[0005] Type I diabetes is generally diagnosed in juveniles and
young adults. In type I diabetes, the pancreas does not make
insulin, which is necessary for the body to process sugars. Persons
with Type I diabetes can live long, healthy lives, but must be
careful with their diet and must take insulin to manage their blood
glucose levels. Currently, the only treatment for Type I diabetes
is to take insulin, or receive pancreas or islet cell
transplants.
[0006] Multiple sclerosis (MS) is a chronic, unpredictable disease
of the nervous system that afflicts over 2.5 million persons
worldwide. An MS attack destroys myelin, the protective fibers
around nerve fibers in the central nervous system. The destroyed
myelin is replaced by scars of hardened "sclerotic" tissue, and
some nerve endings are permanently severed. The common symptoms are
loss of balance, fatigue, poor circulation, slurred speech,
blindness, and in some cases paralysis. Currently, the only
treatment is disease-modifying drugs, including drugs with a
chemotherapeutic agent. These treatments only modify the disease to
lessen the severity or frequency of the MS attacks.
[0007] 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 multiple sclerosis which
has proven successful in controlling epidermal cancers including,
but not limited to, duct cell breast cancer, cervical squamous
cancer, and anal cancer, controlling Type I diabetes, and
controlling multiple sclerosis. 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 containing 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.
BRIEF DESCRIPTION OF THE DRAWING
[0008] 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:
[0009] FIG. 1 is a flowchart illustrating initial steps in the
cancer screening method of the present invention;
[0010] FIG. 2 is a flowchart illustrating subsequent steps in the
cancer screening method of the present invention; and
[0011] FIG. 3 is a flowchart illustrating the diabetes treatment
method of the present invention.
DETAILED DESCRIPTION
Introduction
[0012] 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
multiple sclerosis.
EXAMPLE
[0013] Referring to the Drawings, and particularly to FIG. 1
thereof, the early steps in the method of cancer screening of the
present invention are shown therein. Screening begins with
administration of the testing procedure known as Blood CA 27,29.
The Blood CA 27,29 testing procedure has heretofore been utilized
in monitoring the results of existing cancer treatment procedures.
However, the Blood CA 27,29 procedure has not heretofore been used
for cancer screening.
[0014] 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 ten (10) 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.
[0015] If the number comprising the result of the Blood CA 27,29
procedure is 20 or above, or if there has been an increase of 10 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.
[0016] Referring to FIG. 2, if the results of the needle biopsy
testing procedure are negative, both the mammogram testing
procedure and the Blood CA 27,29 testing procedure are
re-administered in six months. If the needle biopsy testing
procedure is positive, a positron emission tomography (PET) scan
testing procedure is administered. 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.
[0017] The cancer treatment procedure of the present invention
comprises the transdermal administration of the drug imiquimod
combined with a vaccine containing tumor necrosis factor and
administration of valacyclovia hydrochlorine tablets. Imiquimod is
commercially available from 3M Pharmaceuticals under the trademark
ALDARA.TM.. 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, i.e. ALDARA.TM.
cream, turns into 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.TM. cream 5% is mixed at a 1:1 ratio with H base cream. The
ingredients of H base cream are: [0018] water, glycerin, canola
oil, stearic acid, cetyl alcohol, PEG-100 stearate, glyceryl
stearate, dimethicone, magnesium aluminum silicate, propylene
glycol, triethanolamine, polysorbate 60, xanthan gum, bitter almond
kernel oil, aloe vera, grape seed extract, wheat germ oil, vitamin
E acetate, vitamin A palmitate, Vitamin C palmitate, tetrasodium
EDTA, potassium sorbate, diazolidinyl urea. H base cream is a
proprietary product produced by Professional Compounds Centers of
America and licensed by it. The mixture of imiquimod and H base
cream as described above is administered transdermally, preferably
by mixing 1/4 cc ALDARA.TM. 5% cream with 1/4 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.TM. 5% cream and H base
cream is applied daily.
[0019] 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 included in the BCG vaccine and imiquimod,
i.e. ALDARA.TM. 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.
[0020] In accordance with the present invention, the vaccine is
given in doses of 0.1 mL (100 .mu.g) once every three weeks as long
as the treatment continues. Valacyclovia hydrochlorine tablets,
available from GlaxoSmithKline under the trademark Valtrex.TM. is
drug commonly used in the treatment for genital herpes. In
accordance with the present invention, Valtrex.TM. tablets are
consumed twice daily in 500 mg doses. The combination of the
ALDARA.TM. and H base cream, the BCG vaccination, and the
Valtrex.TM. 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.
[0021] Referring to FIG. 3 thereof, persons with Type I diabetes
must check their blood glucose levels at multiple intervals as
directed by their physician. The average fasting blood glucose
level should be between 70 mg/dL and 110 mg/dL. If the blood
glucose level is not within the target level, the level must be
corrected by taking insulin.
[0022] 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.TM.. 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, i.e. ALDARA.TM. cream, turns into interferon
alpha once inside the human body, providing the needed interferon
alpha not adequately produced by the patient's own body.
[0023] In accordance with the present invention, ALDARA.TM. cream
5% is mixed at a 1:1 ratio with H base cream. The ingredients of H
base cream are: [0024] water, glycerin, canola oil, stearic acid,
cetyl alcohol, PEG-100 stearate, glyceryl stearate, dimethicone,
magnesium aluminum silicate, propylene glycol, triethanolamine,
polysorbate 60, xanthan gum, bitter almond kernel oil, aloe vera,
grape seed extract, wheat germ oil, vitamin E acetate, vitamin A
palmitate, Vitamin C palmitate, tetrasodium EDTA, potassium
sorbate, diazolidinyl urea. H base cream is a proprietary product
produced by Professional Compounds Centers of America and licensed
by it. The mixture of imiquimod and H base cream as described above
is administered transdermally, preferably by mixing 1/4 cc
ALDARA.TM. 5% cream with 1/4 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.TM. 5% cream and H base cream is
applied daily.
[0025] 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 included in the BCG vaccine and imiquimod,
i.e. ALDARA.TM. 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.
[0026] In accordance with the present invention, the vaccine is
given in doses of 0.1 mL (100 .mu.g) once every three weeks as long
as the treatment continues. Valacyclovia hydrochlorine tablets,
available from GlaxoSmithKline under the trademark Valtrex.TM. is
drug commonly used in the treatment for genital herpes. In
accordance with the present invention, Valtrex.TM. tablets are
consumed twice daily in 500 mg doses.
[0027] 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.
[0028] 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.
* * * * *