- - - Results of Brain Tumor Trials - - -
(as of November 2001)
Over 100 clinical trials using different chemotherapy regimens have been conducted on recurrent brain tumors. The general consensus is that such tumors cannot be cured by chemotherapy, and the response rate is only modest. Complete responses are almost never seen, and the total response rate usually includes stable disease. Even though some of these studies report significant responses, the durations of improvement are short. Ultimately, almost all of these patients die from their brain tumors. Patients who are being treated with antineoplaston therapy often are the exception.
Antineoplastons have been used to treat neoplastic disease since the 1970s. Patients can tolerate administration of antineoplastons very well, for as long as approximately 10 years in one case.
The Burzynski Research Institute currently sponsors 72 different Phase II clinical trials with Antineoplastons A10 and AS2-1 in different forms of cancer. Five of these trials have reached the final point and proved antincancer activity in various types of malignant brain tumors.
CAN-1: Results in 35 Evaluable of 43 Total Patients
Complete response (CR) 25.7% Progressive disease 20%
Partial response (PR) 22.9%
Stable disease (SD) 31.4%
CR + PR (objective response) 48.6%
CR + PR + SD 80%
The largest group of patients was diagnosed with glioblastoma multiforme and the second largest with anaplastic astrocytoma.
BT-9: Phase II Study of Primary Brain Tumors in 13 Evaluable of 20 Patients
Complete response (CR) 23.1% Progressive disease 7.7%
Partial response (PR) 30.8%
Stable disease (SD) 38.5%
CR + PR (objective response) 53.8%
CR + PR + SD 92.3%
Most of the patients were diagnosed with astrocytoma.
BT-11: Phase II Study of Brain Stem Gliomas in 18 Evaluable of 25 Patients
Complete response (CR) 16.7% Progressive disease 33.3%
Partial response (PR) 22.2%
Stable disease (SD) 27.8%
CR + PR (objective response) 38.9%
CR + PR + SD 66.7%
The patients treated were diagnosed with brain stem glioma.
BT-13: Phase II Study in Children with Low-Grade Astrocytoma in 8 Evaluable of 9 Patients
Complete response (CR) 37.5% Progressive disease 0%
Partial response (PR) 25.0%
Stable disease (SD) 37.5%
CR + PR (objective response) 62.5%
CR + PR + SD 100%
The patients treated were children diagnosed with astrocytoma.
BT-15: Phase II Study in Adult Patients with Anaplastic Astrocytoma in 16 Evaluable of 23 Patients
Complete response (CR) 12.5% Progressive disease 37.5%
Partial response (PR) 12.5%
Stable disease (SD) 37.5%
CR + PR (objective response) 25.0%
CR + PR + SD 62.5%
The patients treated were diagnosed with anaplastic astrocytoma which did not respond to radiation therapy and/or chemotherapy.
BT-18: Phase II Study of Mixed Gliomas in 11 Evaluable of 14 Patients
Complete response (CR) 27.3% Progressive disease 45.4%
Partial response (PR) 9.1%
Stable disease (SD) 18.2%
CR + PR (objective response) 36.4%
CR + PR + SD 54.6%
The patients treated were diagnosed with mixed glioma.
Adverse Reactions to High-Dose Treatment
Almost all patients
experience increased urine output and slight thirst. The treatment usually is
free from adverse reactions or is associated with mild side effects. Moderate
side effects (Grade 2 by NCI criteria) include fluid retention, hypernatremia,
hypocalcemia, hypokalemia, hypomagnesemia, nausea and vomiting, elevation of
SGPT, leukopenia, allergic skin
rash, fever, chills, headache, tinnitus and decreased hearing, decreased and
blurred vision.
Serious adverse
reactions (Grades 3 and 4 by NCI criteria) were observed in only a small number
of cases and included high serum sodium levels (0.9%); low calcium levels
(0.6%); low magnesium levels (0.3%); low potassium levels (0.3%); elevations of
serum bilirubin (0.3%), SGOT (0.2%), and SGPT (0.3%); and thrombocytopenia
(1.1%). It is suspected that in many cases, neurologic toxicity, visual
toxicity, and ototoxicity resulted from the brain tumors. Serious
thrombocytopenia occurred in only one patient who
received combination chemotherapy 6 weeks before administration of
antineoplastons, which could have contributed to bone marrow suppression.
Generally, adverse reactions were fully reversible.
NOTE: Most patients who come to Dr. Burzynski already have failed at least one type of therapy and many have failed more than one type. Many of these patients are considered to be in the final stages of cancer and have no remaining conventional treatment options available to them.