Cancer Vaccine Questions
What is the treatment process?
The treatment process involves four phases of treatment. Phase one is evaluation of the patient’s current condition, diagnosis, and medical history. The most important factors in this phase are indicators of a competent immune system. A list of medical records and necessary historical items are included in this site. Phase one concludes with evaluation of the patient by one of our staff physicians at our offices in the Caribbean. Phase two begins with drawing blood from the patient to begin the preparation of the vaccine. Within 2 or 3 days after the blood draw, the patient is prepared for surgery. Surgery is done to obtain a tumor sample and debulk the tumor, if necessary. The tumor specimen is sent immediately to the GARM Laboratories for beginning preparation of the vaccine on the day of surgery. Vaccine #1 preparation takes approximately 5 days and is administered as soon as it is ready. The patient goes home for a month. Phase three involves evaluating the patient, and administering vaccine #2 in our offices. Vaccine #2 will have been created in the 30 days since vaccine #1 is administered. The patient is observed for 3 days and discharged home. Phase four involves evaluating the patient and administering vaccine #3 in our offices. Vaccine #3 will have been prepared during the 30 days since vaccine #2. Although not usually the case, administration of subsequent vaccines may be necessary.
What is the scientific basis for this treatment?
This treatment is based on autologous programmable dendritic cell vaccines prepared from each patient’s stem cells. This vaccine is unique to each patient and your specific tumor. It is prepared from precursor cells obtained from your blood. Those cells are trained to attack your tumor. Autologous refers to the fact that the vaccine is prepared using the immune cells obtained from your blood and tissue obtained from your tumor that was surgically removed for your body. The vaccines are not created with material obtained from another person, animal, or toxic chemicals. Most patients will receive a course of four injections, approximately one month apart.
If a patient is interested in seeking this treatment, what steps should he/she take?
Please visit the Contact Us page
How can I find out if I am a candidate for this treatment?
Since your physical condition, previous treatment and tumor type is unique to you, we would recommend a Comprehensive Cancer Consult at our office to see if your unique situation is a candidate for this treatment. Not all patients will meet criteria for this treatment.
How long does it take to make the vaccine?
In order to create a vaccine made uniquely for you we must first have a sample of your blood and a sample of your tumor. Once we have those it will take approximately one week for completion of your vaccine.
How long does the treatment take?
The treatment is composed of four vaccines administered approximately one month apart resulting in a four month treatment period.
Is this treatment FDA approved?
No, this is not an FDA approved treatment.
Can the tumor that my surgeon removed from me at the time of my original surgery be used to make a vaccine?
No. When your surgeon originally operated on you, the entire specimen was sent to pathology where it was processed in a manner rendering it useless to our process.
What exclusion criteria are there?
You must have an intact immune system. There are certain tests we may recommend to assess the competency of your immune system. Recent chemotherapy is usually an exclusion criterion. Your immune system will be cleared by GARM physicians before any treatment will proceed.
Can I have received other treatments before trying this immunotherapy?
Yes. Some patients have concluded other treatments. Steroids and chemotherapy must be discontinued for at least 45 days prior to evaluation. Each patient is evaluated individually for his unique situation. This is an alternative treatment. Each patient has to be thoroughly assessed individually.
Can I have other treatments for my cancer before this treatment?
Yes. If these other treatments fail, then we could always discuss the possibility of trying this type of approach at a later date. You must remember that time is of the essence, and you need to have a competent immune system to increase the chances for success.
Can I have chemotherapy and radiation prior to this therapy?
Chemotherapy and radiation are devastating to your immune system. Even your normal immune response is destroyed by chemotherapy and radiation. The ability to stimulate the enhanced immune response necessary for the success of this treatment may be destroyed by chemotherapy and radiation prior to initiation of this treatment.
If I choose this treatment, what do I do if it fails?
There are two choices. First you could always discuss the traditional treatment options after documented failure of this treatment. Alternatively, we could prepare additional vaccines specifically for you from the original preserved tumor specimen. We have the capability of preserving your tumor for up to two years.
What side effects have you seen in your patients?
Because this is an autologous vaccine, adverse events are minimal. Some patients have symptoms suggestive of coming down with the flu, occasionally with muscle aching and a feeling of tiredness. Swelling and inflammation at the site of the tumor occurs due to the local reaction of the destructive process on the tumor by your own immune system.
How long do I have to wait after chemotherapy to have this treatment?
You must wait long enough for your immune system to regain its functionality. We have treated patients following chemotherapy. Empirically, it takes about six months for the immune system to recover from the insult of chemotherapy. You must be cleared by a participating GARM physician to proceed with this treatment.
How much does this treatment cost?
This is a very expensive procedure and exact costs depend on the surgery performed, the patient’s individual recovery needs and period. Patients should be prepared to incur a significant expense. This fee is for the consultation, vaccines, and all office visits/procedures preformed at the GARM facility. It does not cover hospital fees for surgery or travel to and from our office, accommodations or incidentals while there. We are more than happy to assist in making these arrangements for you and your family at our low negotiated rates once you have been established as a qualified patient.
Is this treatment covered by insurance?
No, insurance will not reimburse you for this treatment.
How long does the complete process take from taking the initial blood draw to returning home?
Phase one involving the initial blood collection, surgery, postoperative recovery, and administration of vaccine #1 takes about 4 weeks. Phase two that occurs one month after phase one consists of evaluation and administration of vaccine #2 takes about 3-5 days. Phase three that occurs one month after phase 2 consists of evaluation and administration of vaccine #3 takes 3-5 days. Subsequent administration of vaccine, if necessary, takes 3-5 days. These are estimated guidelines. Each patient’s response to therapy is unique as each patient’s situation is different.
How is the vaccine administered?
The vaccine will be administered with four subcutaneous injections given approximately one month apart. You will receive your first vaccination after your surgery before you return home.
Do you have any guarantee this will work?
As with any medical procedure, outcomes are multi-factorial and depend largely on individual responses. There are no guarantees.
What are the risks?
The risks of this type of treatment are mostly associated with the normal risks of surgery. Our physicians will review the risks and benefits of surgery with you prior to scheduling your procedure. The risks associated with the drawing of blood and the administration of the vaccine are usually minimal and may consist of, but not be limited to, bruising, fainting, headache, nausea, limited local reaction with swelling and irritation, fever, stiffness. An anaphylactic reaction is rare, but possible.
Why aren’t you involved in FDA clinical trials?
FDA clinical trials take several years and are very expensive. The majority of our patients do not have several years to wait on approval. Keep in mind this is an autologous vaccine, produced from your own stem cells…..there are no experimental drugs being introduced during this procedure.
Where are the procedures performed?
The consult, the surgery and the administration of the vaccine will be performed in facilities in the Caribbean.