Coley Fluid was a mainstream cancer therapy for many years, but its use declined with the advent of chemotherapy. In 1962, an amendment to the Federal Food, Drug, and Cosmetic 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. 
 

William Coley        

Coley Fluid has been known by many different names: Coley Vaccine, Coley’s Toxins, Coley’s Mixed Toxin, Coley’s Mixture, Erysipelas and Prodigiosis Toxins, Febrivax, Multi Bacterial Vaccine, and Vaccineurin. 

Coley Fluid is a sterile mixture of killed bacteria that induces an intense immune response against cancer and other diseases. It was developed by William Coley in 1893 and has not been commercially available since 1951, but continues to be remembered by medical researchers, physicians and patients for one simple reason – sometimes it worked. 

The first patient to receive Coley Fluid was a sixteen-year-old boy with a massive abdominal 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 tumour gradually diminished in size. By May 1893, after four months of intensive treatment, the tumour 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.

Many historical cancer patients, including patients who would be considered incurable today, experienced complete regression of disease and lived long lives without recurrence of cancer: 

• An extremely sick woman with widely spread ovarian cancer received fifteen months of Coley Fluid therapy beginning in 1916, and completely regained her health until she died suddenly of a cerebral hemorrhage 20 years later. 
• A patient with recurrent melanoma received injections of Coley Fluid in 1902 and remained well without further recurrence for 41 years. 
• A patient who had become paralyzed due to a massive tumor involving the spine received injections for three months in 1902, completely recovered, and lived a normal life without further recurrence for 42 years. 
• A patient with egg-sized tumors in the neck and jaw, received six months of Coley Fluid therapy in 1906 during which the tumors entirely disappeared without further recurrence for 46 years. 
• A patient with inoperable bone cancer received six months of Coley Fluid therapy in 1909 and went on to live a normal life without recurrence for 42 years.
• A 42 year-old woman in a rapidly declining state of health with an inoperable tumor the size of an orange in her left breast received three months of therapy in 1895, completely regained her health and lived to the age of 89.
• A 43 year-old woman with advanced cervical cancer received three years of therapy beginning in 1899 and lived a normal life until dying of influenza at the age of 79.
• A 27 year-old woman with inoperable kidney cancer received four months of Coley Fluid therapy in 1912. When this woman was last traced in 1952 there had been no recurrence of cancer.

These remarkable examples of long-term complete regression of cancer were unknown until the mid-1950s when the Cancer Research Institute published a series of monographs detailing the complete medical histories of hundreds of Coley Fluid patients. These publications generated a renewed interest in Coley Fluid. By 1955, the Cancer Research Institute was producing Coley Fluid for experimental use. By the mid-1960s when the FDA put a stop to the practice, the Cancer Research Institute had distributed over 1,500 vials (about 15,000 doses) of Coley Fluid to physicians. Very little has been published about this program except for one case reviewed in 1989 in the journal Cancer Surveys:

“… a recurrent terminal adenocarcinoma of the colon with metastases seeding the viscera and peritoneum, liver, pleura and lungs with ascites  and pleural effusion. Prognosis was less than a week. This male, aged 69, had lost 28 pounds and had signs of obstruction leading to complete ileus: dyspnoea, nausea, vomiting and hepatomegaly. The abdomen was tapped daily, yielding 4 to 6 quarts of bloody fluid, and every two or three days a quart of bloody pleural effusion containing the malignant cells (grade III) was evacuated. Dr James Ricks of Oklahoma City gave him the Coley toxins [Coley Fluid] daily for eight days beginning on February 22, 1961. They were given intradermally in the abdominal wall causing a local inflammatory reaction, generalized aching, chills and fever to 103°F. The pleural effusion diminished after the first injection. There was no further ascites after the third injection. The patient returned home by March 10^th. His weight and strength increased. Complete regression occurred and he remained free from further evidence of disease when last traced in February 1969, 10½ years after onset.” 

There are dozens of similar accounts of desperately sick cancer patients who received Coley Fluid therapy, completely recovered, and went on to live normal lives. However, these examples are considered medical anecdotes – after the fact examples that have been selected using unknown rules of selection from an unknown number of cases. Medical anecdotes, while sometimes persuasive, prove nothing. For medical proof, the gold standard is a clinical trial in which patients are recruited, treated, and evaluated according to written standards, the results to be achieved are prospectively determined, and an Institutional Review Board of experts not personally engaged in the clinical trial oversees the integrity of the process. 

Coley Fluid has been an enduring medical controversy for more than one hundred years. While some investigators believe Coley Fluid and other broad-spectrum immune therapies are the future of cancer therapeutics, most continue to believe the best road forward is refinement of chemotherapy and radiation combined with therapeutics that target specific molecules associated with cancer. Which path is correct? This important question effecting millions of lives has remained unresolved for too long. In October 2005, a diverse group of 35 scientists, physicians, and others with an interest in immune therapies founded MBVax Bioscience to generate new data for an old therapy that may hold great promise for the future. 

Note: The original references for this material are included in documents available for download under Publications – in particular see Coley Fluid – Mechanism and Studies, Dr William Coley and tumour regression: a place in history or in the future, and Spontaneous Regression: Cancer and the Immune System.