All U.S. patients must participate and be treated under a current FDA-approved clinical trial or Special Exception. Residents of most other countries must receive FDA permission to ship antineoplastons to that country. All patients are treated on an outpatient basis. The treatment is self administered and normally free of serious side effects.

During the initial consultation, Dr. Burzynski or his associate will meet with the patient, review the patient's previous medical history, perform an examination and brief the patient on the recommended treatment plan.

There are two different routes of administering antineoplastons: 1. Intravenous (I.V.) infusion through an I.V. catheter and ambulatory pump. 2. Orally, in capsule form.

Patients on intravenous treatments will need to plan a two to four week stay in Houston, which will involve daily patient evaluation and intensive instruction for patients and relatives (or other care-givers) in the care and use of catheter and pump. After an initial consultation with Dr. Burzynski, any necessary diagnostic testing will be ordered and scheduled. It is required that patients receiving I.V. therapy have an intravenous catheter placed. If you are accepted for IV treatment and don’t already have a catheter in place, arrangements can be made with a local surgeon to perform the insertion.

Surgical placement of a catheter is a simple procedure which can usually be performed on an out-patient basis under local anesthesia. The preferred placement is in the vein which runs in the upper part of the chest under the collarbone, or clavicle (sub-clavian). This placement permits normal hand and arm movement and is easy to keep clean due to its location.

When the catheter is in place, injections or drip can be easily given by the patient or family members, who will be instructed in this procedure. Taking care of the catheter is a simple process of regularly applying antiseptic solution and antibiotic ointment to the incision and changing the sterile dressing over the catheter.

The patient and accompanying family members or care-givers will also receive intensive training from the medical staff on programming and care of the portable infusion pump. Patients who receive their therapy in this way lead normal lives because the pump, which is similar to those used by diabetics, is easily carried in a moderately sized canvas bag, or fanny pack. The pump can be disconnected for up to three hours.

Once the patient’s tolerated dose has been established, the patient is stable and has demonstrated the ability to care for the catheter and program the pump, the patient will be provided with a treatment plan to meet his or her medical needs until the next visit approximately one month later.

Patients receiving the oral medication will need to plan a three to five day stay. After the initial consultation with Dr. Burzynski, the necessary diagnostic tests will be ordered and scheduled. The patient will be monitored to evaluate the proper dosage. Once this is established, the patient will be provided with a treatment plan to meet his or her medical needs until the next visit approximately one month later.

In addition to 24 hour on-call emergency care, Dr. Burzynski's medical staff monitors patient progress on a daily basis once the patient is released from the office.

Patients participating in controlled clinical trials will be required to come to the office once each month for a three-day followup. Monthly consultations will include review of the appropriate diagnostic tests indicated in the clinical trial protocol or as required to meet the patient's medical needs.

Patients on high dosages of antineoplastons will need to find a physician back home to participate in their care. This physician need not be an oncologist, but may be a family practitioner, internist or other specialty. Since this is an FDA requirement, and we do not know in advance which patients will be on high dosages, we cannot begin administering antineoplastons until the patient finds a physician to fulfill this role. We will send the necessary forms for participating physicians when the appointment is made for an initial consultation.

Initial response to the antineoplastons can be evaluated by standard diagnostic tests, usually within four to eight weeks. The average length of time during which patients receive antineoplastons ranges from four months to one year.

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