Human / Clinical Studies
In 1987, patients with a variety of advanced malignancies participated in a retrospective selective case series study of antineoplaston A5. Patients ranged in age from 43 to 71 years. Only patients who were expected to survive for at least 6 weeks and who continued the treatment for at least 6 weeks were eligible. Patients received A5 through IV subclavian vein catheter. Treatment lasted from 47 to 130 days. Side effects included chills and fever in five patients, arthralgia in one patient, and premature heart beats and chest pressure in one patient. An increase in platelets and white blood cell counts were noted, as was hypertrophy of the epidermis. One patient had complete tumor response, and there were two partial responses. Stable disease was reported in seven patients. Disease progression occurred in four patients.
Studies of Specific Malignancies Treated with Antineoplastons
A 1995 phase I study from Japan investigated the use of antineoplastons in conjunction with radiochemotherapy and surgical resection in patients with malignant brain tumors. Nine patients were diagnosed with the following brain tumors: three cases of glioblastoma, two cases of anaplastic astrocytoma, one pontine glioma, one medulloblastoma, one metastatic brain tumor, and one case of multiple brain metastases. All patients received some form of chemotherapy and radiation, with the exception of the patient with multiple brain metastases. Most patients underwent surgical resection of the tumor, with the exception of the cases of pontine glioma, multiple brain metastases, and metastatic brain tumor. Patients with glioma were treated with remission maintenance therapy. Nimustine or ranimustine was administered over intervals of several months; at 2-week intervals, the patients received interferon-beta and an antineoplaston. The study does not indicate which antineoplastons were used.
One complete response was achieved in a patient with anaplastic astrocytoma. This response was seen within 4 weeks and lasted for 6 months, at which time the patient developed recurrence in another part of the brain. Two patients (one case of pontine glioma and one case of metastatic brain tumor) achieved a partial response. In two patients, no change in disease status was reported, while four patients had disease progression. Adverse effects of antineoplaston therapy included itchy skin rash, stiff finger joints, flatulence, and mild myelosuppression.