ANTINEOPLASTON INFORMATION Antineoplastons: Two components: Atengenal (Antineoplaston A10, " Bag 1" or "A bag" ) and Astugenal (Antineoplaston AS2-1, "Bag 2" or "B bag"): Atengenal (Antineoplaston A10) composition: A synthetically derived sterile solution in a 4:1 ratio of sodium phenylacetylglutaminate and sodium phenylacetylisoglutaminate. Atengenal (Antineoplaston A10) mechanism of action: It is believed, from laboratory studies, that Astugenal (A10) inhibits the production of proteins in cancer cells, which is necessary for continued life and function of the cancer cells (by inhibiting incorporation of the amino acid glutamine in the production of proteins). 1 Astugenal (Antineoplaston AS2-1) composition: A synthetically derived sterile solution in a 4:1 ratio of sodium phenylacetate and phenylacetylglutaminate. Astugenal (Antineoplaston AS2-1) mechanism of action: Cancer results from the increased activity of oncogenes (cancer genes) and the decreased expression of tumor suppressor genes (genes that decrease or halt cancer). It is believed, from laboratory studies, that AS2-1 modulates the expression of the ras oncogene (subsequently causing reduction of the multiplication of cancer cells) and the tumor suppressor gene p53 causing cancer cell death. 2 Antineoplaston infusion: Antineoplastons are infused intravenously every 4 hours (6 times a day) because they are broken down quickly in the body and after 4 hours there is a significantly decreased therapeutic level of antineoplastons remaining in the body. Atengenal (A10) - On day one of treatment, an initial test dose of Atengenal (A10) will be given followed by a starting dose 5 times that day for a total of 6 doses daily. In adults, we will increase the dose every day (as tolerated), initially by 40 milliliter increments 6 times per day until we reach 200 milliliters 6 times per day, then by 20-milliliter increments 6 times per day until the maintenance dose is reached. In children <12 years old, we will increase the dose every day in 10-milliliter increments 6 times per day, >12-18 years old we will increase the dose in 20-40 milliliter increments 6 times per day until the maintenance dose is reached. Astugenal (AS2-1) - On day one of treatment, an initial test dose of Astugenal (AS2-1)will be given. In adults, we will increase the dose every few days (as tolerated), by 10-milliliter increments 6 times per day until the maintenance dose is reached. In children < 12 years old, we will increase the dose every few days in 5-milliliter increments 6 times per day, >12-18 years old we will increase the dose in 5-10milliliter increments 6 times per day until the maintenance dose is reached. Pump for infusion of antineoplastons: A portable programmable pump infuses antineoplastons intravenously automatically. Initially, the pump will be running continuously (with a slow rate of fluid infusion after the antineoplaston infusion is complete) to keep the central venous catheter line (or port) open and keep it from clotting. You will be taught by our intravenous (IV) nurses how to prepare the antineoplaston bags, how to program the mini pump, and how to troubleshoot problems related to the pump. Our nurses are very knowledgeable concerning the infusion pumps; therefore, please address any questions or problems related to the pump to the intravenous nurses in I.V. suites 235 or 236 or after hours via our answering service to the nurse on call. Page 1 of 13 Antineoplaston maintenance dose: The maintenance dose of antineoplastons (the dose that the patient will eventually remain on) is based on the patient's weight and is different for each patient. The maintenance dose will probably not be reached before you leave Houston. The dose of antineoplastons will continue to be increased at home until the maintenance dose is reached (which your doctor will calculate). Please note that the calculated effective maintenance doses are averages and since all patients are different, your tumor may respond to a higher or lower dose of antineoplastons than other patients. Antineoplaston Shipping: The shipping of antineoplastons should be at a controlled temperature within the storage range (15-30 degrees Celsius or 59-86 degrees Fahrenheit). Antineoplastons should be visually inspected immediately before each use. If the solution appears cloudy or discolored, it should not be used but returned to us immediately for analysis. We ship antineoplastons all over the world so there should be no problem for you to get antineoplastons at your home. We ship a 15-day supply at a time due to the large amount of medicine and the weight as well as necessity to keep the medicine from expiring before it can be used. At discharge, you will receive a 15-day supply of medicine (unless you express otherwise due to traveling size and weight constraints). You will pick up your initial discharge antineoplaston medication supply with a written prescription given to you at discharge on the first floor in suite 125 (take a right as you exit the elevator and this suite is located in the first door on your left). Please let Jerzy know if you would like to take a smaller supply than prescribed home and he can ship the remaining 15-day supply. We use Federal Express and routinely ship antineoplastons via regular service, which typically arrives in 3 business days (at no cost to the patient). However, we can ship antineoplastons via priority or overnight service, which should arrive the same day or the next day respectively (with a shipping charge billed to the patient) which should not be necessary if an accurate drug inventory is kept. Also, there is no one available in our shipping department on weekends or holidays, so let us know in advance when you are getting low on your antineoplastons so we can ship them out during the week. Antineoplaston Storage: Antineoplastons should be stored at room temperature (15-30 degrees Celsius or 59-86 degrees Fahrenheit) without refrigeration or freezing. Antineoplaston Inventory: Once you return home, you will be asked to keep an accurate daily count of your antineoplaston supply (drug inventory). This is very important so you don't run out of medicine as well as a cross check to make sure you are taking the proper prescribed dose of antineoplastons (and not under or overdosing antineoplastons thereby jeopardizing your health). ALWAYS note the expiration date on the antineoplaston bags. DO NOT use expired antineoplastons. Special or Compassionate Exception (CE): Patients who do not meet the regular protocol criteria to participate in our clinical studies can be granted a special or compassionate exception by the: Institutional Review Board (IRB) 9432 Old Katy Road Suite 370 Houston, Texas 77055 713-365-0222 This board is a separate entity from the Burzynski Research Institute. Please note that it usually takes at least 24 - 48 hours for the board to review and grant provisional approval for patients to start antineoplastons. The full board will review the compassionate exception at their next meeting to discuss final approval. Page 2 of 13 Food and Drug Administration (FDA) Approval: Patients with extenuating circumstances (above and beyond those for special or compassionate exception) that make them ineligible to participate in our regular protocols must receive approval from the FDA and IRB to be eligible to participate in our clinical studies. Please note that this usually takes 24 - 48 hours for FDA approval AND an ADDITIONAL 24 - 48 hours for IRB approval. Central Venous Catheter Placement: A subclavian central venous (Hickman single lumen) catheter (a catheter in the vein of the upper part of the chest just below the clavicle or collar bone) will be inserted prior to starting antineoplastons so that we can infuse antineoplastons intravenously or through a vein. Dr Stenoien (Dr Lee in his absence) at Houston Medical Imaging (see page 6 for address and phone #) will perform this as an outpatient in their office with a local anesthetic (numbing) of the chest. We will provide you with a map to their office. It is normal for the first 1 to 2 weeks while the catheter is healing for the area around the catheter to be slightly tender to touch, painful, red , warm or with some clear to bloody discharge. After the first 1 to 2 weeks when the catheter is healed, these can be signs of infection and must be attended to immediately. Therefore, if you notice any of these problems, notify your doctor immediately and he/she will start antibiotics to prevent or treat an infection. Wellmaintained central venous catheters or ports can remain in place for years, if necessary, without infection. We will remove your suture or stitch in our office approximately 1 week after the catheter was inserted. Dressing changes, flushing, disconnecting, and reconnecting and medication administration via the catheter: The nurses will teach you how to do central venous catheter dressing changes every 3 days. It is very important to keep the catheter clean and dry and use sterile technique while changing the catheter dressing, flushing, disconnecting and reconnecting, and administering medications. This is a catheter in the vein; therefore, a patient who has an immune system that is weakened by cancer can get an overwhelming and sometimes fatal infection via the central venous catheter or port. After you are comfortable with sterile flushing, disconnecting, and reconnecting the central venous catheter (or port), you may disconnect the patient from the pump and reconnect just prior to the next scheduled infusion of antineoplastons. This will give the patient some freedom from lugging the pump around continuously. Please note that this will be approximately 1 week after start of treatment. Also, the time disconnected will become less as the antineoplaston dose is increased since the antineoplaston infusion time will be longer. Blood work: Blood work will be drawn prior to antineoplaston treatment (as baseline) and every other day after starting treatment (through the catheter so you won't need to be poked). This is to determine any potential problems before you even experience any symptoms. (For example, you may be required to take supplemental oral potassium if your potassium level in your blood becomes low.) Blood work will be drawn at home after discharge every other day while the dose of antineoplastons is being increased, then 3 times per week (Mondays, Wednesdays, and Fridays) when the maintenance dose of antineoplastons is reached. The frequency of blood drawing will be reduced to twice weekly once you are clinically stable and have been on a stable dose of antineoplastons for at least 60 days. For your safety, it is imperative that your blood work be faxed to us the same day it is drawn, so we can make any necessary changes in your medications as soon as possible. Page 3 of 13 Contraception: Since we do not know (at this time) the effects of antineoplastons on pregnant women or unborn children, it will be necessary for potentially fertile women who are currently menstruating or have not had a hysterectomy or completed menopause to use contraception to prevent pregnancy while receiving antineoplastons. Contraception can be by injection, pills, or use of condoms. Men receiving antineoplastons who have not had vasectomy must use condoms during intercourse at all times. These requirements must be adhered to the entire time the patient is participating in the study. Please note that there MAY BE NO ill effects of antineoplastons on pregnant women or unborn children, but this information is unknown at present. Therefore, this is a precaution to protect you and potential unborn children. Medications: We will maintain a record of all prescription medications (including milligram dosage and frequency taken per day) while you are enrolled in our study. Please bring all your prescription medications to our office for your initial office consultation. This will help in the prevention of drug interactions and accidental overdosing and underdosing. 1) Steroids: As tumor cells die, there will be increased swelling or edema in the brain and around the tumor due to your body sending in cells to clean up and remove the dead tumor. We try to prevent and offset this swelling by starting or increasing the dose of, if you are already taking, an oral steroid such as Decadron or dexamethasone at the beginning of treatment. This prevents symptoms of increased swelling or edema such as seizures, headaches, nausea, vomiting, visual changes, etc. During the course of your treatment, it may be necessary to switch the oral form of Decadron to the IV form. The IV nurses will teach you how to administer IV Decadron via the subclavian catheter. Decadron can also cause some irritation of the stomach in some patients; therefore, we will also start a medicine to protect the stomach from irritation (Zantac, Pepcid, Tagamet, Axid, Prevacid, Aciphex, Nexium, or Prilosec). 2) Anticonvulsants: Most patients with brain tumors have seizures due to increased pressure on the brain; however, some patients do not. If you are already on anticonvulsant(s)[anti-seizure medication(s)] prior to treatment with antineoplastons, then we will continue your anticonvulsant(s) during the entire course of the treatment. We anticipate that as we increase the dose of antineoplastons, the anticonvulsant level(s) will drop. During administration of antineoplastons, there is increased elimination of urine which may result in losses of anticonvulsants through the kidneys, resulting in a lower level of anticonvulsant(s) in the blood with a higher risk of seizure(s). We will be monitoring your anticonvulsant level(s) in your blood and probably increasing the dose of the anticonvulsant(s), as we increase the dose of antineoplastons. Supplements: We will maintain a record of all nonprescription medications including over-the-counter medications, supplements, herbs, vitamins, etc. (including milligram dosage and frequency taken per day) while you are enrolled in our study. Please bring all your nonprescription medications to our office for your initial office consultation. This will help in the prevention of drug interactions, and accidental overdosing and underdosing. Vitamin B12 and Folate (Folic acid): Vitamin B12 and folate may promote cancer growth; therefore, if you are taking a multivitamin which contains B12 and folate, we will obtain a B12 and folate level via a blood test and if these levels are high, we will ask you to stop your multivitamin. If these levels are normal, you may continue your multivitamin. Page 4 of 13 Fluid Input and Output: You will be required to maintain a record of your fluid intake (to include your I.V. antineoplaston infusions) and urine output daily while you are increasing the dose of antineoplastons. The purpose of this is to prevent dehydration and edema or swelling. The goal is to take in a slightly greater fluid amount than you put out to prevent dehydration. However, taking in too much fluid compared to your urinary output, will result in edema or swelling. As you can see, there is a balance here. You will be taking in more fluids each day while you are increasing the dose of antineoplastons (from an increased volume of fluid as the dose of antineoplastons is increased) as well as drinking more fluids due to increased thirst. You will also be urinating more due to drinking a larger volume of fluids and also due to a " diuretic effect " (increased fluid output) of the antineoplastons. Your body will get used to the increased amount of fluid intake over a few week period. If urinary output becomes overwhelming, you may consider having a urinary catheter placed. Urinary Catheters: Urinary catheters can be placed (in our office) if urinary output becomes overwhelming. The placement of a urinary catheter increases the risk for a urinary tract infection (especially in patients whose immune system is weakened by cancer); however, we are monitoring you daily for symptoms of infection as well as doing a urinalysis frequently which can detect a urinary tract infection early in patients who have no symptoms. Urinary catheters come in the form of indwelling foley catheters which remains in the bladder with a portable bag or a leg bag and condom catheters (for men only) which can be removed during the day and used only at night or may also be used the entire day. Time duration in Houston: Adults are required to stay a minimum of 15 consecutive days and children are required to stay a minimum of 21 consecutive days in Houston from and including the first day of treatment (not 15 days from the first consultation date). If the patient is clinically stable on the 15th or 21st day respectively for adults and children, they will be seen for the last time in the clinic that day, and may return home later in the day or that evening. If you are uncomfortable with any aspect of the treatment, you are welcome to stay longer in Houston (as long as it takes for you to feel comfortable with all aspects of the treatment). Hospitalization: Should hospitalization be necessary during your stay in Houston: Adults or children older than 14 years will be referred to: Memorial Hermann Memorial City Hospital 921 Gessner Road Houston, Texas 77024 713-242-3000 under the care of: Adeeba Akhtar M.D. 902 Frostwood Suite 246 (Medical Plaza 1) Houston, Texas 77024 713-468-2358 Fax: 713-468-2595 Children less than 5 years old will be admitted to The Texas Children’s Hospital (in the Texas Medical Center) 6621 Fannin Street Houston, TX 77004, 832-824-2300. Page 5 of 13 Psychological Referrals: We will be glad to refer you to a therapist/psychologist to help assist you in dealing with issues related to a chronic disease or care giving Pharmacies: We use 4 local pharmacies primarily for your convenience but will be glad to use any pharmacy you desire for your medication needs. Southern Family Pharmacy 9432 Katy Freeway, Suite 277 Houston, Texas 77005 Pharmacist: Yvonne Remo R.Ph. 713-335-5640 CVS Pharmacy 9455 Hammerly (at Blalock) Houston, Texas 77055 713-722-1490 Walgreen's Pharmacy 9329 Katy Freeway (I-10 @ Echo Lane) Monday - Friday 9 AM - 10 PM Saturday 9 AM - 6 PM Sunday 10 AM - 6 PM Location: Hedwig Village Shopping Center next to Kroger 713-461-3607 For emergencies: 24 Hour Walgreens Longpoint @ Bingle 713-468-7813 When you return home, we will be glad to call your medications to your local pharmacy. Magnetic Resonance Imaging (MRI s): Baseline MRIs and CTs in Houston will be done primarily at: Houston Medical Imaging 7000 Fannin Suite M-40 Houston, Texas 77030 713-797-1919 Fax 713-383-9933 since they are the promptest at scheduling our patients. If your insurance will not pay for MRIs or CTs done here or if you need to use another facility for any reason, we will be glad to accommodate you; however, these scans may take longer to schedule at another facility. A map to the imaging facility will be provided for your convenience. Most protocols require a follow up MRI or CT every 4 to 8 weeks from start of treatment, initially. Your research associate will let you know the exact frequency of scans required by your individual protocol. If you take your baseline (most recent) scans home with you, you will need to send them back with your new scans for comparison. We will ALWAYS need the previous (most recent) scans along with the current scans for comparison! Therefore, please have the facility that does your scans send us both a written report and the actual scans for our review. Page 6 of 13 Local doctor: It is common sense for any patient who has a chronic disease, including cancer, to have a regular established local doctor in case of emergencies. The FDA wants to ensure this, so they require that your local doctor signs a form called the 1572 that states, in writing, that your doctor agrees to take care of you at home. Let us know at the beginning of your treatment your doctor's name and address and we will send them a packet of information about our treatment and the 1572 form. We must have this signed 1572 form back prior to your departure from the clinic. We know your local doctors are busy; therefore, we try to send these packets the first day of treatment so that your doctor will have time to read, sign and send the 1572 back to us prior to your discharge. Your doctor can be as little or as much involved with our study as they desire and we try to make everything as easy as possible on them. Therefore, we will be giving you all orders for MRI and CT scans and blood work, interpreting these, making changes in your medications, and calling in refills and other medications to your local pharmacy. If you are a member of a PPO or HMO insurance in which your local doctor must order your blood work and scans for insurance to pay, it will be necessary for your doctor to cosign our orders. The minimal responsibility of your local doctor will be: 1) Perform a physical examination every 4 weeks. The physical examination must be documented on a 1 page simple form that we will supply to the doctor. Your first physical examination at home is required 4 weeks from your initial physical examination at our clinic (not 1-month from discharge). 2) Evaluate and treat any problems or symptoms that we cannot evaluate over the phone. Doctors at the Burzynski Clinic: There are several doctors who work with antineoplaston patients at our clinic: S.R. Burzynski M.D., Ph.D. - Principal investigator Robert A. Weaver M.D., C.P.I. - Co-Investigator, Certified Physician Investigator Barbara Szymkowski M.D. - Research Associate Sheryll Acelar M.D. - Research Associate Alejandro Marquis M.D. – Senior Physician Marek Walczak M.D. – Research Associate Shah Alam M.D. - Research Associate Eva Kubove M.D., C.C.R.C. - Research Associate, Certified Clinical Research Coordinator Lourdes DeLeon M.D. – Research Associate Tolib Rakhmanov M.D. - Research Associate Dr. Weaver will perform your physical examinations and evaluate you every weekday while you are in Houston, and supervise your care via the research associates once you return home. The research associates will obtain your initial medical history, evaluate you on weekend days in Houston,and once you return home, will call you to review blood tests, make medication changes, and address any problems or symptoms. The same research associate who takes your initial medical history will follow you the entire time you are participating in the study. Radiology Consultation: Mohammad Khan M.D. or Vsevolod (Sev) Dolgopolov M.D. will review your baseline MRIs or CT scans with you and compare them to your most recent prior films (if available) in Suite 205 at the beginning of your treatment. Nurses: o Clinical Research Coordinators (CRCs)/Monitor nurses: Marilyn Threlkeld L.V.N., C.C.R.P. (Certified Clinical Research Professional) will call you daily ( for patient safety) once you return home. They will ask questions concerning new/continued symptoms or problems (adverse events), new medication or medication dosage changes, and your antineoplaston supply. Please let them know what a convenient time will be for them to call, and provide them with an alternate number when you will be away from home. Page 7 of 13 o Intravenous (I.V.) nurses (suites 235 or 236): Cesar Diaz R.N. Marlene Bestak R.N., B.S.N. Juanita Brown R.N. Ivette Ureste L.V.N. o Patient Support Group Coordinator/In-house nurse: Marlene Bestak R.N., B.S.N. Patient Support Group: Marlene Bestak R.N., B.S.N. leads a Burzynski Clinic patient support group on Mondays from 5 - 6:30 PM in the library of our clinic (located down the hallway to the left of the waiting room). Medical assistants: Beata Rusak C.M.A. Krystyna Dolomisiewicz C.N.A.,C.M.A Amanda Loya M.A. Dietary Consultation: As part of your treatment, you will have a consultation with one of our dieticians, Donna J. Christoffel, M.S., R.D. - nutritionist or Vickie Cambron R.N., usually within a few days of starting antineoplastons. They will discuss a low sodium (Na) diet (usually 2 grams or 2000 milligrams per day) due to the large sodium content of the antineoplaston solution, increased potassium (K) intake since most patients tend to lose potassium due to Decadron, increased fluid intake, calorie requirements, supplements, vitamins and other topics customized to each patient's medical history and specific needs. Financial Issues: Please address all financial or insurance questions and issues to your assigned financial assistant: Deborah Jurida 713-335-5613 Shirley Maneli 713-335-5608 Maggie Jordan 713-335-5623 Estela Rocha 713-335-5668 The Burzynski Breakthrough: The Burzynski Breakthrough, written by Thomas D. Elias, is a book which recounts the trials and tribulations of the Burzynski Clinic and antineoplastons and a story about hope in the fight against cancer. It is available at our front desk. Operating a motor vehicle: Texas law prohibits a patient with seizures from operating a motor vehicle if they have had a seizure within 6 months. We DO NOT recommend any patient with a brain tumor (even those who have never had a seizure) operate a motor vehicle (car or airplane) because there is the potential of developing dizziness or an initial seizure causing harm to themselves or others. Please review your local laws for patients with seizures or brain tumors operating motor vehicles or the Federal Aviation Administration (FAA) regulations regarding piloting an airplane. Burzynski Clinic Address: 9432 Katy Freeway, Suite 200 Houston, Texas 77055 Page 8 of 13 Clinic Hours: Monday - Friday: 9 AM - 5 PM Saturdays, Sundays and holidays: 9 AM - until the last patient leaves the clinic Appointments: Appointments will be made for you at your convenience by our front desk staff between the hours of 9 AM and 5 PM on weekdays and between the hours of 9 AM and 12 noon on weekends and holidays. Our doctors try to spend as much time with you as you need; therefore, please try to be on time for your appointment out of respect for other patients, so you don't intrude on other patient's appointment times. Please be patient on weekends and holidays, since you may have to wait slightly longer due to a reduced staff. Burzynski Clinic fax number: 713-935-0649 Burzynski Clinic phone number/24-hour answering service: 713-335-5697 We have a 24-hour answering service to accommodate questions or problems. If you have a medical question or problem after the clinic is closed, please call our main number above and ask for the doctor on call for antineoplastons. One of the above research associates will call you back and answer your questions and evaluate your problems. Please call with prescription and antineoplaston refills on weekdays only, since the doctors on-call on the weekends and holidays will be handling urgent calls. Our nurses are very knowledgeable concerning the infusion pumps; therefore, please address any pump questions or problems to the nurse on call. We encourage you to call early if you suspect a problem rather that delaying and having a minor problem turn into a major one. Security: Monday through Saturday, you may enter the building via the front or rear entrances. For Sundays, you must sign out a keycard from the receptionists on Fridays which will allow you to enter the rear of the building by sliding your keycard through the machine located adjacent to the rear doors. If this does not work, use the intercom system by pushing the button on the gray box next to the door and the IV nurses will push a button that will allow you to open the rear door. When leaving the building on Sundays, you can only exit via the rear doors. Push the green button on the right wall next to the rear doors, which will allow you to exit. You must return your keycard to the receptionists on Monday; otherwise, you will be charged to replace the card. Parking: Patients with handicap stickers on their vehicles may park in the marked handicap spaces reserved in front of the building or on the first floor of the parking garage behind the building. Patients without handicap stickers on their vehicles may park in any unreserved or nonhandicap spaces surrounding the building or in the parking garage behind the building in any unreserved or nonhandicap spaces (but not in the fire zone on the west side of the building). There is no charge for parking. Page 9 of 13 Signed Informed Consent for treatment: Signed informed consent will be required prior to a patient starting a drug study protocol. This simply means that the patient has read the consent form in their own language (interpreters available upon request) and understands the risks and benefits of the drug study and knowingly and voluntarily is participating in the study. If a patient is mentally incompetent to sign the consent form or is younger than 18 years old, then an immediate family members such as a parent, spouse, siblings or adult child older than 18 years old may sign the consent form. If the patient is a minor (< 18 years old) but understands the concept of voluntarily participating in a research study (usually 12 years old or older), he/she should sign the consent form to signify that he/she has assented to participate in the study. If the patient is accompanied by a friend or relative who is not one of the above mentioned individuals, then a medical (not financial) power-of-attorney form for the patient will be required for this person to sign the consent form. Compliance: The FDA requires patients participating in drug studies to adhere and comply STRICTLY with written drug study protocols to ensure patient safety. This includes doing physical examinations, having blood work and scans as scheduled and taking the correct prescribed dose of medication. Repercussions for NOT adhering to the protocol can be temporary or permanent suspension of the study medication! Orphan Drug Designation (ODD) The FDA notified the Burzynski Research Institute on September 7, 2004 that it had granted its petition for Orphan Drug Designation for Antineoplaston infusions for the treatment of brain stem gliomas. This designation is the culmination of many years of dedicated effort and represents a major milestone on the long road to market approval since many orphan products receive expedited review from the FDA for market approval. The FDA's orphan drug program encourages research, development and approval of products for rare diseases and for drugs that provide a significant therapeutic advantage over existing treatments. Orphan Drug Designation may be granted by the FDA for a drug which treats conditions or diseases that affect less than 200,000 persons annually in the United States. Since antineoplastons has not yet received market approval, insurance companies may not reimburse for drug expenses; therefore, consult your insurance company for specific reimbursement policies. Discharge: On the day of discharge, you will be given a discharge summary and monthly physical exam forms for your local doctor, a 10 day supply of antineoplastons, written orders for your follow-up scans and blood work, a letter informing airline personnel that you will have in your possession study medication and supplies(including needles) and you will meet your assigned monitor nurse. Please plan to spend an extra 1 - 1 1/2 hours in the clinic that day to complete these tasks. Suggestions: We truly APPRECIATE your COOPERATION! Hopefully , this summary will be helpful to you throughout the course of your treatment. We value your input; therefore, please let us know if you have any comments or suggestions. If you ever have a problem or question you feel is not being addressed adequately, please contact me directly ! Have a pleasant stay in Houston and a safe trip home. Robert A. Weaver M. D,, C. P. I. Certified Physician Investigator Page 10 of 13 REFERENCES 1 Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent Diffuse Intrinsic Brain Stem Gliomas - Drugs R & D 2003; 4(2): page 10-11. 2 Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent Diffuse Intrinsic Brain Stem Gliomas - Drugs R & D 2003; 4(2): page 12. Page 11 of 13 ANTINEOPLASTON INFORMATION INDEX PAGE ADEEBA AKHTAR M.D. ………………………………………………………………………………5 ANSWERING SERVICE (24 HOUR)…………………………………………………………….. 9 ANTICONVULSANTS…………………………………………………………………………….. 4 ANTINEOPLASTON A10…………………………………………………………………………. 1 COMPOSITION………………………………………………………………………………. 1 MECHANISM OF ACTION…………………………………………………………………. 1 ANTINEOPLASTON AS2-1………………………………………………………………………. 1 COMPOSITION………………………………………………………………………………. 1 MECHANISM OF ACTION………………………………………………………………… 1 ANTINEOPLASTON "A BAG"…………………………………………………………………………………….. 1 "BAG 1"……..……………………………………………………………………………… 1 "BAG 2"…………………………………………………………………………………….. 1 "B BAG"……………………………………………………………………………………. 1 INFUSION…………………………………………………………………………………… 1 INVENTORY…………………………………………………………………………………. 2 MAINTENANCE DOSE…………………….……………………………………………….. 2 SHIPPING…………………………………………………………………………………….. 2 STORAGE…………………………………………………………………………………….. 2 APPOINTMENTS…………………………………………………………………………………… 9 ASTENGENAL……………………………………………………………………………………… 1 ASTUGENAL……………………………………………………………………………………….. 1 BLOOD WORK……………………………………………………………………………………. 3 BURZYNSKI BREAKTHROUGH……………………………………………………………….. 8 BURZYNSKI CLINIC ADDRESS…………………………………………………………………………………….. 8 ANSWERING SERVICE (24 HOUR)……………………………………………………… 9 CLINIC HOURS……………………………………………………………………………… 9 DOCTORS……………………………………………………………………………………. 7 FAX……………………………………………………………………………………………. 9 PHONE NUMBER…………………………………………………………………………… 9 CENTRAL VENOUS CATHETER DRESSING………………………………………………… 3 CATHETERS URINARY…………..………………………………………………………………………….. 5 CENTRAL VENOUS…………………………………………………………………………. 3 CLINIC HOURS……………………………………………………………………………………. 9 CLINICAL RESEARCH COORDINATORS (CRCs)…………………………………………… 7 CONSENT FOR TREATMENT………………………………………………………………….. 10 CONTRACEPTION……………………………………………………………………………….. 4 COMPLIANCE……………………………………………………………………………………. 10 CVS PHARMACY……………………………………………………………………………….... 6 DIETARY CONSULTATION…………………………………………………………………….. 8 DISCHARGE DAY………………………………………………………………………………… 10 DISCONNECTING/RECONNECTING TO THE CENTRAL VENOUS CATHETER……… 3 DOCTOR (LOCAL)………………………………………………………………………………… 7 FAX NUMBER……………………………………………………………………………………… 9 FINANCIAL ISSUES………………………………………………………………………………. 8 FLUID INPUT AND OUTPUT…………………………………………………………………….. 5 FLUSHING THE CATHETER……………………………………………………………………. 3 FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL…………………………………. 3 FOLATE (FOLIC ACID)…………………………………………………………………………… 4 HOSPITALIZATION………………………………………………………………………………. 5 Page 12 of 13 ANTINEOPLASTON INFORMATION INDEX (CONTINUED) HOUSTON MEDICAL IMAGING……………………………………………………………….. 6 MAGNETIC RESONANCE IMAGING (MRI)………………………………………………….. 6 MEDICAL ASSISTANT...…………………………………………………………………………. 8 MEDICATIONS……………………………………………………………………………………. 4 MEMORIAL HERMANN MEMORIAL CITY HOSPITAL…………………………………………5 NURSES…………………………………………………………………………………………….. 7, 8 OPERATING A MOTOR VEHICLE…………………………………………………………….. 8 ORPHAN DRUG DESIGNATION (ODD)……………………………………………………….. 10 PARKING…………………………………………………………………………………………… ..9 PATIENT SUPPORT GROUP……………………………………………………………………. 8 PHARMACIES (LOCAL)…………………………………………………………………………. 6 PSYCHOLOGICAL REFERRALS………………………………………………………………. 6 PUMP………………………………………………………………………………………………… 1 RADIOLOGY CONSULTATION………………………………………………………………… 7 REFERENCES……………………………………………………………………………………… 11 SECURITY………………………………………………………………………………………….. 9 SOUTHERN FAMILY PHARMACY…………………………………………………………….. 6 SPECIAL OR COMPASSIONATE EXCEPTION (CE)…………………………………………. 2 STEROIDS………………………………………………………………………………………….. 4 SUGGESTIONS…………………………………………………………………………………….. 10 SUPPLEMENTS……………………………………………………………………………………. 4 TEXAS CHILDREN’S HOSPITAL……………………………………………………………….. 5 TIME DURATION IN HOUSTON……………………………………………………………….. 5 VITAMIN B12………………………………………………………………………………………. 4 WALGREEN'S PHARMACY……………………………………………………………………… 6 WALGREEN'S 24 HOUR PHARMACY…………………………………………………………. 6 Revised 3/30/05 Page 13 of 13