Experimental Protocol: Immunization against Cancer Cells using Interleukin-2 and Macrophage Colony Stimulating Factor, James McCoy, Ph.D.
Robert and Marylyn Kruecke
I was advised by a client with Mesothelioma to contact James L. McCoy, Ph.D, who is the director of research for the Immunocomp Laboratory, Inc., located in Baton Rouge, Louisiana. My client has been very positive about Mr. McCoy (I will use the "Mr." title not out of disrespect but to distinguish him from a medical doctor). My client, Mr. Kruecke, lives in Wisconsin. He was diagnosed with pleural mesothelioma in February of 1996. He has a partial pneumonectomy and had part of his diaphragm removed. He and his wife had a phone conference with Dr. David Sugarbaker at Harvard about follow up surgery but was not accepted. Mr. Kruecke and his wife first met Mr. McCoy at a lecture of his in 1996. They they have provided the Immunocomp Laboratory with tumor specimens from which Mr. McCoy's lab has attempted to create a "vaccine."
I wrote to Mr. McCoy and he was kind enough to provide me with several articles about his immunization protocol. I will summarize them here from a layman's point of view.
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James McCoy, Ph.D is the director of the Immunocomp Laboratory, Inc, located at 11832 Newcastle Avenue, Suite 17, Baton Rouge, LA 70816. His phone number is 504-293-3698 and his fax number is 504 292 5466. You should write to him and request his patient packet if you want to learn more. Additionally, please consult with Mr. McCoy before you rely on my interpretation of his materials (I don't have a Ph.D in immunology and I'm not a medical doctor!). I am not aware whether McCoy's research results have been peer reviewed or published.
McCoy was formerly employed at the National Cancer Institute as a Staff Immunologist. You might want to review the Primer above to better understand the medical jargon and the goals and mechanisms of immunotherapy.
The title of the protocol is "Experimental Protocol for Immunization of Cancer Patients with Immunotherapy Treatment Containing Tumor Associated Antigens Formulated with Low Doses of Interleukin-2 and Granulocyte Macrophage Colony Stimulating Factor." The experimental protocol paper is dated January 2, 1997. Attached to the paper are several charts dated February 3, 1997 which evaluate the clinical toxicity of the immunotherapy for specific cancers, e.g., breast cancer, colon cancer, mesothelioma, etc. As of February 3, 1997, 292 patients were enrolled in the "cancer vaccine program." Of those patients, five (5) had mesothelioma. Four (4) of the five (5) received vaccine (presumably the four living mesotheliotics). The immunotherapy treatment for mesotheliotics first began in May, 1996.
Based on a total of 33 immunizations (I am presuming among the four living patients), none of the mesothelioma subjects showed severe clinical symptoms (e.g., nausea, vomiting, fever, chills, rapid heart rate, confusion, labored breathing, fatigue, etc.). 29% of the injections resulted in mild swelling or redness at the site of the injection, 12% showed mild labored breathing, and 6% resulted in mild fatigue and weakness. No immunizations showed any signs (mild or severe) of nausea, fever, chills, rapid heart rate, confusion, muscle aches or pains, diarrhea, loss of sleep or reduced urination. So far so good.
A chart was provided that indicates the ratio of patients receiving immunotherapy treatment who demonstrated clinical responses. "Clinical Response" is defined as "stabilization of disease, partial shrinkage, complete remission (via CT scan or drops in tumor markers)." Of the five mesotheliotics who participated, McCoy was able to conduct a clinical evaluation on four patients. Of these four, one showed a clinical response (a 25% response ratio). There is no data on whether the response by the one positive patient was shrinkage, stabilization or remission.
Note: the average positive response for all 162 patients who were evaluated (with cancers ranging from breast cancer to colon cancer and from ovarian cancer to lung cancer, among others), was 22.8%. The mesothelioma patient sample, however, was limited to four patients.
Another table, also dated 2/3/97, is entitled "Patient Blood Mononuclear Cell Reactivity Against Cancer Antigens Pre and Post Immunization with Cancer Vaccine". A patient is considered to have a positive reactivity when the test results are equal to or greater than 1.10. There are two columns: one for Pre Vaccine and the other for Post Vaccine. For Mesothelioma, 67% of the patients reacted positively in the pre-vaccine stage, for an average positive value of 2.7. As a benchmark, the average positive value for prostate was 4.23 and breast cancer 3.3. 100% of the post vaccine mesothelioma patients reacted positively, for an average value of 2.36. To put that number is perspective, the average positive values for post vaccine breast cancer, colon cancer, lung cancer and prostate cancer were 5.45, 7.31, 4.4, and 18.74, respectively.
James McCoy, Ph.D is the Study Director and he is joined by a medical doctor, Dr. Rhett Bergeron. Physicians and oncologists are participating in the study by administering the immunotherapy treatment to their patients and monitoring the patient's clinical status.
The Goals of the study include (1) to evaluate the safety/toxicity of cancer immunotherapy treatment customized to the patient following weekly immunizations, (2) to evaluate the efficacy of these cancer immunotherapy treatments in inducing tumor shrinkage or remission as determined by CT scans, etc, (3) to measure survival, (4) to evaluate hypersensitivity responses, and (5) to determine whether patient's lymphocyte reactivity in vitro against tumor associated antigens (TAA) develops following immunotherapy treatments.
RATIONALE OF THE STUDY (I am paraphrasing from the paper here)
Human tumor cells have TAAs that can stimulate the patient's lymphocytes and macrophages. Based on positive results with breast cancer patients who underwent immunotherapy, if immunity against TAA could be induced in breast cancer patients, then it is possible that these patient's newly acquired immunological responses might result in partial or complete clinical remission of their cancers.
McCoy proposes that if the same cell surface membrane TAA that was used in the breast cancer study was used along with safe, non toxic levels of lymphokines/cytokines (naturally occurring white blood cells that activate macrophages and proliferate T lymphocytes), then an immunotherapy can be developed that will trigger a high cancer cell kill. The treatment consists of three ingredients: (1) a TTA that is customized from the patient's tumor specimen, (2) low dose granulocyte macrophage-colony stimulating factor (GM-CSF), and (3) low dose interleukin-2 (IL-2, which induces the proliferation of T Lymphocytes).
The treatments are injected into the groin area below the inguinal nodal beds, which warehouse the body's lymphocytes and macrophages. A series of immunological events occurs. The body's macrophages are activated by the GM-CSF, which then process the TAA and send it over to the T lymphocyte, which has been programmed to recognize the TAA as foreign. IL-2 causes the proliferation of T lymphocytes with anti-TAA killing capacity. The new T Lymphocytes, now armed with cytoxic-killer power, then circulate in search of cancer cells with TAA on their cell surface.
The patient must have a firm diagnosis of cancer. The patient is usually 65 years old or older. Most will have advanced metastatic disease. Conventional therapy options will have been exhausted.
IMMUNOTHERAPY TREATMENT PREP
The TAA's are prepared from the patient's own tumor specimen. The tumor specimens must be sent to the Immunocomp Lab at least 14 days prior to the preparation of the immunotherapy treatment. Patients are required to provide a fresh or frozen (non-formalin fixed) biopsy of their tumor, or at least two needle biopsies collected with an 18 gauge needle (or larger gauge). The Lab will separate the cell surface membranes from the tumor cells. These cell surfaces are rich in TAA. The cell surface membrane TAA will be evaluated for safety/toxicity in humans. A prior study relied upon by McCoy found no adverse side effects following intradermal injection of these TAA into 104 patients.
ADMINISTERING THE TREATMENT
Only medical doctors or their assistants are allowed to administer the two drug agents (IL-2 and GM-CSF) and the TAAs. The cocktail will be injected in the primary physician's office. The patient will receive a total of 12 immunizations, consisting of 3 injections (one injection of each type of drug agent) once a week for 12 weeks.
I was not provided with the costs. Again, this material to my knowledge has not been peer reviewed, is experimental, and you should pose your questions directly to McCoy before deciding whether you want to participate. Your primary doctor must also be willing to try something new. RGW