Coley's Clinical Trial

The Advanced Alternatives Coley's Cancer Vaccine Clinical Trial

Advanced Alternatives, LLC is pleased to announce that it is participating in an exciting new clinical trial involving Coley's cancer vaccine. Coley's is a natural treatment for cancer. It uses natural chemical substances, those produced by microorganisms, as the basis for the medication. The natural chemicals are thought to be 1) toxic to cancer cells, 2) strong stimulators of the immune system, and 3) inducers of fever, a natural from of internal hyperthermia therapy. Decades of use, plus recent clinical studies, suggest that Coley's is safe and effective. The current Advanced Alternatives Coley's Clinical Study is the most recent attempt to further define the potential benefits and any side effects of Coley's using a modern day protocol. The Advanced Alternatives Coley's Clinical Study offers the medication supply FREE of COST to those individuals with cancer who wish to become part of the study as study subjects. There will be no charge to the patient for administering the medication since this is a clinical trial and the medication is not yet a commercial product. Our purpose in being a part of this clinical trial is to help advance health care science and see to it that our clients have access to all the most promising new natural treatments, even when they are not part of the Advanced Alternatives Natural Cancer Care Program.

How to Enroll in the Study

This study focuses on the effects of Coley's Cancer Vaccine on patients who have existing cancer. Even though we normally think of vaccines as preventive agents, Coley's is not designed to prevent future cancers. It is a testing-stage treatment for cancers already present, whether early or late stage cases. Potential study subjects can choose between two ways to participate in the study. The first is to receive their supply of Coley's Cancer Vaccine free, and have the Coley's medication administered at no additional charge when they are enrolled in the normal Advanced Alternatives Cancer Program. The other option is to receive the supply of medication free, and request that a charity or other organization sponsor your treatment and pay for the costs of having it administered. We do not charge our clients any fee for this medication or for administering it. See further notes on this option below.ⁱ Contact us via this website for more information or to apply, or by emailing us at aacancer@gmail.com.

History of Coley's Cancer Vaccine

Coley's vaccine has a long and interesting history. Once used as the mainstay in American oncology for bone and other cancers, Coley's fell into disuse after the advent of chemotherapy. Coley's vaccine has been known by various other names including Coley's fluids, Coley's toxins, Coley's Mixed Toxin, Coley's Mixture, Erysipelas and Prodigiosis Toxins, Febrivax, Multi Bacterial Vaccine, and Vaccineurin. MBVax Bioscience provides Coley Fluid for research and clinical study.

Coley Fluid was a mainstream cancer therapy for many years, but its use particularly in the United States declined with the advent of chemotherapy. In 1962, an amendment to the Pure Food and Drug Act established the present system of FDA approval. The amendment included a "grandfather clause" that legalized drugs currently being marketed. Unfortunately, in 1962 no U.S. companies were marketing Coley Fluid so in spite of a 70-year history of safe and effective use, beginning in 1962 Coley Fluid was no longer an approved therapy in the United States.

In 1982, researchers determined 5-year survival of historical Coley Fluid cancer patients was equivalent to 5-year survival of modern patients. In 1999, researchers found 10-year survival of historical Coley Fluid patients was better than modern sarcoma, kidney and ovarian cancer patients. In addition to prolonging survival, Coley Fluid was frequently curative in types of cancer that are incurable today.

The Amazing Story of Dr. Coley

William Coley, M.D. was a leading oncologist in 19th Century America. From the turn of that century until the 1930's his innovative cancer vaccine was arguably the leading form of cancer treatment in the United States. It was government approved, and accepted by leading hospitals in the USA. Dr. Coley and his cancer vaccine seem to have been ahead of their time. It all started when Dr. Coley treated a boy ill with a large abdominal malignant tumor. Every few days, Coley injected his fluid directly into the tumor mass and produced the symptoms of an infectious disease, but did not produce the disease itself. On each injection, there was a dramatic rise in body temperature and chills. The tumor gradually diminished in size. By May 1893, after four months of intensive treatment, the tumor was a fifth its original size. By August, the remains of the growth were barely perceptible. The boy received no further anticancer treatment and remained in good health until he died of a heart attack 26 years later.

Coley published his results and by the turn of the century 42 physicians from Europe and North America had reported cases of cancer that had been successfully treated with Coley Fluid. Coley Fluid became a mainstream cancer treatment and was successfully used in the treatment of most types of cancer. Until his death in 1936, Coley was the head of the bone tumor department at Memorial Hospital in New York City where he treated thousands of bone cancer patients with his fluid. In the United States the pharmaceutical company Parke Davis manufactured Coley Fluid until 1951.

The historical results of Coley Fluid therapy are difficult to compare with modern results. Even so, every published study has reached the same conclusion: Coley Fluid therapy is as good, or better, than modern therapies. However, there were many different formulations of Coley Fluid that varied greatly in effectiveness, and there were many different treatment protocols that also varied greatly in effectiveness. The company believes its Coley Fluid formulation and treatment protocol will be more effective than current therapies for a wide range of cancers.

Previous Studies of Coley's

Several studies have been done previously and point ot Coley's as being safe and effective. However, it must be noted that the manufacturer has not yet completed their studies (this study is one of those) and the product is not approved by the FDA. As with all new or modified old mediations, thorough tests and clinical trials are required. The following text, data, and charts are taken verbatim and without modification from the MBVax published materials. "A scientific review of 897 cancer patients treated with various formulations of Coley Fluid up to 110 years ago found that complete regression and 5-year survival occurred in 46% of the 523 inoperable cases and 51% of the 374 operable cases. These results are comparable to modern 5-year survival rates. The National Cancer Institute estimates overall 5-year cancer survival at 35% in 1950-54 and 63.8% in 1992-98.

To determine comparable rates of 10-year survival, in 1999 researchers compared Coley Fluid patients with matched controls from the National Cancer Institute's Surveillance Epidemiology End Result database. The study found higher rates of 10-year survival for Coley Fluid patients compared to modern patients in kidney cancer (33% to 23%), ovarian cancer (55% to 29%) and sarcoma (50% to 38%).

However, retrospective studies underestimate the efficacy of Coley Fluid because:

• There was a wide variability in potency between the more than 20 different formulations of Coley Fluid used to treat cancer patients.
• There was no standard clinical protocol for the administration of Coley Fluid.

If Coley Fluid patients fared as well as modern cancer patients in spite of variations in formulation and clinical protocol, patients receiving an optimized version of Coley Fluid under a proper clinical protocol should fare even better.

To illustrate the importance of formulation, the chart below compares 5-year survival rate by formulation for 137 historical sarcoma patients who received Coley Fluid therapy:

To illustrate the importance of clinical protocol, the chart below compares 5-year survival rate by length of therapy for the same group of historical sarcoma patients:

There have been 63 cases of advanced breast cancer treated with Coley Fluid. Of these cases, the subsequent histories of the 37 patients who received effective formulations were significantly better compared to the 26 patients who received ineffective formulations.

In these charts, the column "apparent cure" refers to patients who had no evidence of disease at the time of their last known medical examination (average 7.8 years after therapy), and the column "more than 2" refers to patients who survived more than 2 years (average survival of these six patients was 8.1 years).

When the eventual fate of these 63 patients is considered in terms clinical protocol, patients treated for at least three months fared much better than those treated for less than three months.

Finally, when we analyze the subsequent histories of advanced breast cancer patients treated with both an effective version of Coley Fluid and for 3 months or longer, the results are very promising.

Since 1960, there have been six clinical trials of Coley Fluid. In these trials, Coley Fluid was tested in patients who were receiving or had previously been treated with chemotherapy and/or radiation therapy. In contrast, at MBVax Bioscience we will study Coley Fluid as a stand alone therapy, that is without the use of chemotherapy or radiation therapy which can suppress the immune system."

1962 - Johnston Trial - various cancers.

• 137 cancer patients, all of whom were considered terminal, received 5,244 intravenous doses, 917 intra-muscular doses, and 41 intra-tumoural doses of Coley Fluid. In one series of 93 patients with progressive disease that no longer responded to chemotherapy or radiation therapy, 43 patients showed no improvement, 20 showed subjective improvements such as weight gain and decrease in pain, and 33 showed measurable improvements including long-term survival and one apparent cure.

1981/83 - Kempin Trial - non-Hodgkin's lymphoma.

• Advanced nodular non-Hodgkin's lymphoma patients were randomized to receive Coley Fluid or no Coley Fluid prior to chemotherapy.

1988 - Axelrod Trial - various cancers.

• 13 patients with "metastatic or locally advanced non-curable disease" received 130 intravenous doses of Coley Fluid. One patient had a partial response and 4 patients had stable disease at the end of 8 weeks treatment.

1991 - Kolmel Trial - malignant melanoma.

• This study focused on 15 patients with advanced melanoma; most had skin tumours, some had metastases into other organs of the body. The treatment consisted of 12 or more weekly intravenous injections of Coley Fluid. The treatment resulted in three total and lasting remissions. One patient achieved a period of stability before the disease progressed. All three patients with complete regressions were disease free at 32, 21, and 15 months. One of the authors of the article, Dr. E. Göhring, used this therapy prior to the study and achieved a complete regression of stage IV melanoma with lung and liver metastases.

1991 - Tang Trial - liver cancer.

• 38 patients with operable liver cancer were randomized to receive, in addition to chemotherapy, Coley Fluid or no Coley Fluid; and 48 patients with inoperable liver cancer were randomized to receive, in addition to chemotherapy and radiation, Coley Fluid or no Coley Fluid. In series 1, the 1- and 2-year survival rates of the Coley Fluid group and the control group were 75% vs 58%, and 45% vs 39%. In series 2, the 1- 2- and 3-year survival rates were 59%, 41% and 41% for the Coley Fluid group and 39%, 25% and 20% for the control group.

1993 - Havas Trial - various cancers.

• 11 cancer patients with refractory malignancies received Coley Fluid as a single agent. One patient had a partial response, four patients had temporary stabilization, and one patient with AIDS and Kaposi's sarcoma experienced a dramatic improvement in performance status and disease stabilization."

The Manufacturer of Coley's Cancer Vaccine

MBVax Bioscience Inc., 1442 Osprey Drive, Unit 4,Ancaster, Ontario, Canada  L9G 4V5, Telephone 905-304-8680, Fax 905-304-9382, is the manufacturer of the study medication and provides it free of charge for the study.  The management team of MBVax is quite distinguished. They include: 1) Don MacAdam, Chief Executive Officer, who is a technology executive. He is the former president of CRS Robotics Corporation, a manufacturer of laboratory robotic systems, and former president and chief executive officer of Tm Bioscience Corporation, a manufacturer of biochips and developer of DNA technologies. Mr. MacAdam is the author of Spontaneous Regression: Cancer and the Immune System; 2) Stephen A. Hoption Cann, Ph.D, Chief Scientific Officer, is an assistant professor in the Department of Health Care & Epidemiology at the University of British Columbia. His research interests include the epidemiology of cancer, the phenomenon of spontaneous regression of cancer, and the work of Dr. William Coley. Dr. Hoption Cann has published 21 peer-reviewed papers, is a reviewer for Postgraduate Medical Journal and Medical Science Monitor: International Medical Journal of Experimental & Clinical Research, and is a member of the American Association for Cancer Research; 3) David Wales, B. Comm., CMA, Chief Financial Officer, has held a number of high-level positions in finance including the senior roles at Tm Bioscience Corporation and CRS Robotics Corporation. In addition to extensive financial experience, Mr. Wales is highly proficient in corporate infrastructure development and business system implementation; 4) Xianghai Chen, MD, PhD (can), Medical and Scientific Director China, is interested in drug development and the clinical application of therapeutics in the fields of genomics, stem cell biology and immunology. Dr. Chen has published 11 peer-reviewed papers, was a cofounder and scientific director of Haiyu Biotech (China), and is one of organizers of the International Association for Biochip Application.

Contact Us Now to Enroll as a Test Subject

Email aacancer@gmail.com or call us now to discover all you need to know about becoming a test subject. The medication is provided at no charge, and the administration of the medication is also provided at no additional charge to patients undergoing the normal Advanced Alternatives Cancer Program. There will be an administration fee for the doctor and clinic time and expenses to administer the mediation if you are not undergoing the Advanced Alternatives Cancer Program.

Addenda

Further Reading and References: 1) Dr William Coley and tumour regression: a place in history or in the future Hoption Cann SA, van Netten JP, van Netten C. Dr William Coley and tumor regression: a place in history or in the future. Postgrad Med J 2003; 79:672; 2) Spontaneous Regression: Cancer and the Immune System Chapter Two, "Coley," from Spontaneous Regression: Cancer and the Immune System by Donald H. MacAdam, Xlibris: Philadelphia 2003; 3) Spontaneous Regression of pancreatic cancer Hoption Cann SA, Gunn HD, van Netten JP, van Netten C. Spontaneous Regression of pancreatic cancer. Case Rep Clin Pract Rev 2004; 1; 4) Spontaneous Regression: a hidden treasure buried in time Hoption Cann SA, van Netten JP, van Netten C, Glover DW. Spontaneous Regression: a hidden treasure buried in time. Med Hypotheses 2002; 58(2):115-9.

Credits: We wish to thank MBVax for making portions of their website and other text and information available to us for use in this article.

Disclaimers: We rely upon information and representations made by the manufacturer MBVax for the information in this webpage. Advanced Alternatives, LLC does not warrant this information as accurate. This FDA has not endorsed or approved the product(s) to be studied in this clinical trial. MBVax informs us that it may use data from the clinical trial to support its future submissions for drug approval for the product in Canada, The United States and other countries.

ⁱ If a charity can be found to reimburse the medical administration costs, it will be to reimburse outside physicians and staff their normal fees for administering this medical care component of the study treatments. This fee can be quoted in advance to a potential sponsoring charity at your request, and may vary slightly from patient to patient depending on their clinical condition requiring more or less intensive efforts from the medical staff that administers the treatments. You are not obligated to become a client of Advanced Alternatives to do this option. We will do our best to help you effectuate this option even if you are not undergoing the rest of the normal Advanced Alternatives program.