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Coley Fluid (Coley's toxins)
In 1891, William Coley of New York's Memorial Hospital developed the most effective single-agent anticancer therapy in the medical literature. It is not in general use today due to a very effective negative propaganda effort within the medical-industrial-regulatory complex of the 1960s, and a lack of contemporary initiative to undo the damage: "There is no question that inappropriate judgments have resulted in injury to good observations: if we look at Coley's toxins, a turn-of-the-century pyrogenic bacterial endotoxin anti-cancer treatment, we see a valid approach to nonspecific host resistance set back by being falsely labeled a 'quack remedy' by the American Cancer Society." (William Regelson. Journal of the American Medical Association. 1980;243(4):337-339).
The five-year survival rates for advanced, inoperable cancers of the breast, ovary, cervix, and uterus, as well as giant cell bone sarcoma and Hodgkin's lymphoma met or exceeded two thirds of all patients treated with Coley Fluid (Coley's toxins) alone. For inoperable melanoma, the five-year survival rate was a remarkable 60%. (Helen Nauts. Cancer Research Institute Monograph No. 18:1984).
These survival rates are all the more remarkable in light of the fact that Coley did not attempt to adjust for many variables, such as nutritional status of the patient, immune competence, negative influences like liquor, tobacco, etc. Further, there were no antibiotics in his time, no heart drugs, no blood pressure drugs, not even insulin (until 1922). Coley simply injected his vaccine (Coley's toxins) repeatedly.
Stephen Hoption-Cann of the University of British Columbia recently wrote: "Despite the 'crude' approach taken by Coley, his vaccine stimulated a complex immune response that could induce the complete regression of both extensive primary and metastatic lesions. Furthermore, his vaccine was universally effective against many types of malignancies. Tumors that were observed to partially or completely regress following treatment with Coley's vaccine included: lymphomas, melanomas, myelomas, sarcomas and a wide spectrum of carcinomas." (Medical Hypotheses. 2002;58(2):115-119). In the same article, Hoption-Cann lamented the fact that standardized cancer management not only fails to consistently produce lasting cures, it has in all likelihood reduced the number of non-treatment-related remissions of the disease: "Modern approaches to treatment have reduced the occurrence of spontaneous regressions. Aseptic techniques and antibiotics significantly reduce postoperative infections, while chemotherapy and radiation impair immune activation even when an infection does occur."
Here are two excellent overviews by Hoption-Cann of the historic development and use of Coley's vaccine: http://www.mbvax.com/pdf/SRegression.pdf, http://www.mbvax.com/pdf/Hoption_Cann_2003.pdf.
Diet therapy (updated and modified Gerson Therapy)
Diet therapy after the manner of Gerson is not understood by us to be a stand-alone treatment for most advanced cancers; however, it IS an indispensable part of integrative immunotherapy for cancer, per se.
How can we make such statements? Our nonprofit scientific research corporation, the Gerson Research Organization, has in its registry 7,785 cases (as of 4/30/2007) from all five (5) Mexican hospitals that offered variants of the Gerson diet therapy for cancer and other diseases from 1977 through 1996 (Hospital La Gloria, Hospital Jardines de la Mesa, Hospital del Sol, Centro Hospitalario Internacional Pacifico, SA, and Hospital Oasis). Of 7,785 charts, 4,738 are cancer cases and comprise our tumor registry. We have published and will continue to publish retrospective analyses of the outcomes of these patients.
In 1958, Max Gerson published a viable "best case series" in his last monograph, A Cancer Therapy: Results of Fifty Cases. In his book, Gerson described the essentials of his treatment, and discussed the rationales known at that time. Unfortunately, the record Gerson left did not yield a "plug-and-play" treatment. Beginning practitioners, indeed even seasoned practitioners, cannot consistently reproduce results like those 50 cases, simply because they were Gerson's best cases.
What emerged as we analyzed the data was a clear picture of clinical benefit. The performance status of even bedridden patients frequently improved to the extent that disabilities were overcome, pain medications were reduced or eliminated, appetite was restored, and patients could again get up and engage family, friends, and community. It became clear that this global improvement also led to the successful employment of additional treatments, e.g. one strong trend in the data is the survival advantage seen in patients who could be operated to remove tumors during or just prior to adherence to diet therapy for melanomas, colorectal cancers, and ovarian cancers. It also became clear that the majority of advanced cancer patients would not be cured by diet therapy as sole treatment.
It is also evident in the historical record that Gerson did not feel that his treatment was complete. Indeed, in A Cancer Therapy, he recommended fever-inducing vaccines, explaining his rationale: "The idea of helping the cancerous organism through a strong inflammation is old but was correct from the beginning." Over 30 years of treating and observing the responses of cancer patients, Gerson came to believe that inflammation and fever were manifestations of healing: "The healing apparatus seems to have retained part of its embryonic capacity and healing purpose for a type of regeneration, when it falls back into the embryonic state temporarily and is activated above the degree of its normal function."
Gerson saw his diet therapy as capable of setting the stage for, and sustaining, a vaccine-triggered inflammatory response: "The completely detoxified body is then able to produce an allergic inflammation if the healing apparatus (liver, visceral nervous system and reticulo-mesenchymal system) can be activated sufficiently. Everything that can help to bring it about and strengthen the necessary allergic inflammation may be used for that purpose after the general detoxification has taken place. Bacterial preparations (Coley and others) or Pyrifer, or any similar preparations are effective, as far as they can stimulate the visceral nervous system in connection with the liver and the mesenchymal defense and healing apparatus." Max Gerson died only months after this monograph was published, and was never able to investigate and develop the combination of his diet therapy and fever vaccines.
Thirty-eight years passed before the exploration envisioned by Gerson began in 1996 as a collaborative effort by the Gerson Research Organization and CHIPSA. Much of the credit for this goes to Wayne Martin and his decision to sponsor and supervise the first new production of Coley's vaccine in decades. Wayne Martin passed away last year, but philanthropic entrepreneur Don MacAdam had already stepped up to fill the void with his creation of MBVax Biosciences and the manufacture of a superbly potent formulation of what is now called Coley Fluid.
Because fevers place an enormous demand on protein reserves, Gerson's lengthy period of protein restriction is not employed by us. Early in the treatment, cultured dairy is added and, depending on the case, fish and fowl may be prescribed within a short time. Protein restriction was part of Gerson's stategy to sensitize the connective tissue immunities in order to trigger a fever, a feat that he could normally accomplish within 6 to 8 weeks.With the introduction of Coley Fluid, it is possible to induce a fever at will, as soon the patient is judged clinically ready.
Photopheresis/dendritic cells
Like Alexander Fleming's serendipitous discovery of penicillin, Carole Berger and Richard Edelson found something they could not have imagined, a way to create professional antigen presenting cells overnight. Their first experiment treating a small amount of patients' blood with a photosensitizing drug and long-wave ultraviolet light (UVA) yielded an impossible-to-believe 40% long-term complete remission rate in cutaneous T-cell lymphoma. These patients would be several decades older, still in complete remission, before Berger and Edelson would learn how they had been cured. Just as Fleming's discovery resulted from accidental mold contamination, Berger's and Edelson's discovery of "overnight dendritic cells" profited from the inadvertent introduction of acrylic plastic to the flow system.
With this principle in mind, it became possible for us to construct a flow system incorporating copious quantities of acrylic cuvette in a circuit including a UVA generator and driven by a Baxter cell separator. Part of the harvest of monocytes in whole blood is cultured overnight in a semipermeable plasma bag. Monocytes are separated from the rest of the harvest, and cultured with IL4, GM-CSF and TNF-ά to produce highly viable dendritic cells (DC), which are administered through a central line and subcutaneously at bilateral axillary and inguinal sites during CF-induced fevers. DC can be injected intratumorally subsequent to peritumoral injections of CF. The capture and culture of monocytes into dendritic cells, and the transfusion of these cells, primes the patient's immune system to recognize "not self" pathogens and to activate lymphocytes to eradicate them. Ironically, this is the same putative mechanism exploited by William Coley more than a century earlier.
A central mechanism
Uwe Hobohm has recently observed in an article about Coley's toxins that the following cascade might explain its effectiveness: "fever generates inflammatory factors with co-stimulatory activity, which activate resting dendritic cells (DC), leading to the activation of anergic T cells, maybe accomplished by a second process, where a possible physical damage of cancer cells leads to a sudden supply of cancer antigens to DC." (Cancer Immunol Immunother. 2001;50:391-396).
In other words, fever is a state in which the body's own self/not-self recognition mechanism turns on to such a high level of activity that it becomes capable of recognizing cancer and microbial invaders. Specialized cells (DCs) then communicate the identity of the pathogen to lymphocytes to establish active immunity against stealth diseases.
Fever is a good thing according to knowledgeable physicians. Cellular damage occurs only at temperatures above 108° F, but much good is accomplished at lower temperatures. To exceed 108° F requires outside influences, whereas the body's internal response to infection (and therefore to bacterial vaccines) is limited to temperatures at or below 106° F.
Transfusing activated DCs into the bloodstream and tissue of patients who are in a vaccine-induced fever is a logical strategy to increase the likelihood of successful immunization. DCs are controlled by the signaling environment in which they function. If transfused into a patient in whom the signaling environment is controlled by malignant or infectious disease, DCs may very likely go to work for the disease. DCs introduced into a signaling environment controlled by an acutely responding self/not-self mechanism, characterized by fever and robust inflammation, will work for the body and against the disease.
Additional support
GKI solutions
In support of antigen presentation and clonal expansion of lymphocytic anti-cancer defences, intravenous glucose, potassium, and insulin (GKI) solutions are given. These work in conjunction with the thyroid of the nutritional immunotherapy to supply insulin-glucose-hungry lymphocytes the energy they need to replicate themselves. For a solid review and discussion of the importance of GKI solutions, look at this link: http://www.jibtherapies.com/content/pdf/1476-8518-3-5.pdf
Testing
Examination of blood, both live and stained, through brightfield and darkfield microscopy, is a routine part of testing and monitoring for success of treatment.
Informed consent and prescriptions for nutritional supplements, medications, and vaccines are provided by our partnering physicians. Intake history and physical, along with examination of scans, may indicate the need for additional diagnostics. High definition ultrasound, CT, and MRI services have been arranged in the event that they are needed.
Ongoing treatment
You will be given vaccines, medicines, and instructions for at least 6 months of at-home treatment with ongoing medical guidance. You will be asked to have periodic blood tests and to supply these to your medical group. During the course of treatment, you may be asked to return for clinical observation and/or to adjust your protocols. Follow-up consultations and observation overnights are often required.
Much information is published on this website, so we suggest that you spend time exploring it and sampling the postings. The more you know going into a consultation, the more likely you are to benefit from our experience and skills.
About cancer
In many ways, cancer looks, behaves, and develops like an infectious disease, with chronic low-level inflammation. Non-healing inflammation tends to cause "sludging" or sticky blood (coagulopathy), depression of circulation in the smallest blood vessels (arteriole-capillary junctions) and, ultimately, hypoxygenation (oxygen starvation) of tissues throughout the body.
Global suppression of whole-body tissue immunities is a consequence of these changes and, logically, the more cancer progresses, the greater the risk for serious infections from microbes that can't hurt or even infect healthy people, e.g. fungal infections.
For most cancers, this tissue damage begins in small pockets and extends with the cancer as it develops. These focal pockets of peritumoral (around the tumor) tissue damage represent a sort of "progressive shock" in miniature, with cells leaking potassium, gaining sodium and chloride, and swelling with too much water.
When a cell swells, its metabolism hits gridlock, oxygen and fuel can't get to the cell's power plants (mitochondria), garbage piles up in the cell's "streets", and the power plants begin to shut down. This leaves the cell barely clinging to life in a "Catch 22" state, in which it lacks the ability to produce enough energy to correct the damage. Physiological Chemistry and Physics and Medical MRI founding editor Freeman W. Cope MD called this "tissue damage syndrome."
Because peritumoral tissue consists mostly of cells in the "Catch 22" state, as tumor burden grows, so does the amount of Catch-22 tissue and so, also, the circulatory problem. At a certain point, call it critical mass, toxic tumor-related substances, putative cancer-related-microbial behaviors, and other influences lead to end-stage deterioration of circulation that is "progressive" in almost exactly the same way that septic shock and hemorrhagic shock are progressive. Failure of the liver, heart, and lungs is a common denominator.
Is there an infectious-disease component in cancer?
Critical observers have for many years argued that cancer must be an infection because of the remarkable similarities: "If it looks like a duck, walks like a duck, and quacks like a duck, it must be a duck." This position was not popular with the cancer-allied industries and was often vehemently attacked as preposterous. Despite having served with distinction as a senior administrator and scientist at New York's Memorial Hospital for 40 years, William B. Coley MD was constantly ridiculed for his viewpoint that cancer must involve infectious processes.
In 1683, looking through the microscope that he had invented, Antoni van Leeuwenhoek observed, "There are more animals living in the scum on the teeth in a man's mouth than there are men in a whole kingdom." A 1998 posting on the US Federal Government Centers for Disease Control and Prevention website described recent tumultuous events in the discovery of new microbes, "Novel kingdoms of life have been discovered with these genotypic methods. It has been estimated that only 0.4% of all extant bacterial species have been identified. Does this remarkable lack of knowledge pertain to the subset of microorganisms both capable and accomplished in causing human disease?"
The obvious conclusion one may draw from this revelation is that Coley was probably correct, and that we have yet to make the basic observations that will eventually unravel the mysteries of cancer. That cancer has responded to general measures, which are considered effective in treating infections, only strengthens this impression. According to David Relman, "In fact, the epidemiologic, clinical, and pathologic features of many chronic inflammatory diseases are consistent with a microbial cause, but intimate or symbiotic host-pathogen relationships are among the most difficult to decipher and mimic in the laboratory" (Relman DA. Detection and Identification of Previously unrecognized Microbial Pathogens. Emerging Infectious Diseases. 1998;4(3) http://www.cdc.gov/ncidod/eid/vol4no3/relman.htm.
The helping hand
Despite the fact that we know almost nothing about thousands of species of bacteria and other microbial lifeforms inside and outside of us, and despite the fact that cancer almost certainly involves, at least in large part, inappropriate overcolonization by unknown and/or unrecognized pathogens, there are general measures that can be taken to enhance our chances of survival and recovery of health.
Hildenbrand and associates have selected only those measures that are associated with positive human clinical outcomes published in an assessible format. Measures are integrated following a lengthy process of study, during which the probable mechanisms of each treatment are considered, along with each treatment's observed clinical benefits and, importantly, limitations.
In all instances, we are looking for a way to help the body restore its lost "self/not-self" detectors. The cancer patient's body does not know it is sick. The two branches of immunity are not talking to each other. The potentially life-saving, cancer-eradicating strike force led by T lymphocytes (the lead-cells of the adaptive immune system) is completely out of the loop, almost like a "Strategic Air Command" having high tea during an enemy missle strike. There are plenty of jets, fuel and bombs, but no one is giving orders to scramble. On the early-detection-and-alert side of things (the innate immune system), our radar dishes are down because "NORAD" (the North American Aerospace Defense Command) has been infiltrated by counterespionage agents. Not only are our best agents (dendritic cells) too few in number, but those that do exist in the cancer patient are unwittingly working for the enemy by sending orders to the connective tissue to support malignant growths, all the while telling T lymphocytes "don't worry about Mr. Malignancy, he is one of "us." T cells that have been tricked become counterespionage agents, spreading the message of "tolerance" for all cancer outposts.
The combined vaccine management can be conceived of as working in the following way: With the introduction by injection of Coley's vaccine, the entire connective-tissue system of innate immunity is put on high alert, and all the alarms go off at once. Most of the NORAD of the innate immune system stops doing what it is doing. The PUVA-photopheresis process literally shines a bright light on the turncoats.
By sensitizing turn-coat cells to UV-spectrum-A light, photopheresis treatment retires sell-out dendritic cells and T cells. At the same time, activated monocytes are recruited and put through bootcamp (mechanical stimulation and overnight growth-factor culture) to make them into special-operations soldiers, i.e., activated dendritic cells. By the same mechanism, photopheresis also lowers the number of circulating invaders (malignant cells, pathological microbes, tumor-associated macrophages) and exposes their antigens (protein markers needed by dendritic cells to show killer-T cells what the enemy looks like).
The cancer-associated-microbial vaccine is a purified antigenic mix of marker proteins bearing the address of one branch of the enemy. This is introduced by injection at the same time that newly-minted, perfectly functioning dendritic cells are injected. With this antigen available, dendritic cells consume it, swim to near neighbor lymphnodes, attract only the appropriate CD8-T cells, and activate them by pushing the antigen into them. Activated T cells begin to multiply into an army of millions within hours.
When T cells attack the tumor and the underlying tissue disturbance (with its putative microbial colonization), a process called adaptive immunization occurs. This is the goal of immunotherapy, because the disease is neutralized, its concomitant tissue damage is healed and, ultimately, the immune system develops a lymphocytic imprint, a permanent memory, of the disease. This is the mechanism by which we become immune to measles or mumps; it provides the certainty that once we have had the disease, we will not get it again. We are protected by our immune-cellular memory of the disease, which includes an early-response component that nips the disease in the bud, before it can re-establish itself.
In conclusion
Our intent is to apply all evidence-based appropriate measures within our grasp to counter the complex and, as yet, unexplained set of pathological changes that occur in cancer. We do not represent our therapy as unique or exclusively correct in any way, and we most certainly do not claim that the US FDA in any way knows about, understands, or approves of the above language or the treatments here described.
The historical record reveals that there have been few systematically applied methods of cancer management associated with credible, positive human outcomes data, meaning long-term, disease-free survival. In fact, relatively few medicines and technologies have been shown to provide benefit of any clinical relevance to malignant diseases, even in an adjuvant role. The identification of the treatments discussed here is based on the available human outcomes evidence. Our group has had long experience with most of these treatments (with the exception of the recently developed PUVA/photopheresis/dendritic cell protocols), and we are convinced of their integrative potential.
In short, the AltCTEP program is but one alternative method of cancer management. There are others, to be sure, and we make no judgments regarding them. We proceed according to our own observations and convictions. We invite you, and our recovered friends invite you, to consider our offering, and we wish you both strength and courage as you confront the challenge of this family of poorly understood diseases. Please feel free to contact us.
Gar Hildenbrand
San Diego, CA
Updated June 2007
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