In 1986, a toxicity study of antineoplaston A10 reported on 18 patients with 19 malignancies. Patients ranged in age from 19 to 70 years. Only patients who completed 6 or more weeks of antineoplaston A10 injections were included in the results. Six of the 18 patients received other antineoplastons in addition to A10. Four patients were administered additional drugs such as antibiotics, analgesics, and anticonvulsants.
Treatment duration ranged from 52 to 640 days. No major toxicities were reported. As with the antineoplaston A study described above, chills and fever were reported in nine patients and occurred only once during the course of treatment. Other side effects noted were muscle and joint pain, abdominal pain, nausea, dizziness, and headache. Partial remission occurred in one patient with chondrosarcoma, and mixed response was obtained in three other cases. Eight patients attained stable disease, and six patients had disease progression. Ten patients discontinued treatment during the study; no reasons were reported. Ten of the 18 patients had died by the time of study publication, 4 years after the start of the study.
A 1986 study examined the toxicity of injectable antineoplaston AS2-1. Twenty patients ranging in age from 17 to 74 years received antineoplaston injections for 21 malignancies. Patients were followed for 5 years. Eight patients received antineoplaston AS2-1 alone. The remaining 12 received other antineoplastons in combination with AS2-1 at different times during treatment.
Side effects associated with AS2-1 treatment included nausea and vomiting, rash, moderate blood pressure elevation, mild electrolyte imbalance, and slightly lowered white blood cell count. Although complete remission was reported in six cases (one case each of stage IV lymphocytic lymphoma, glioma, myelocytic leukemia, intraductal carcinoma of the breast, stage IA uterine cervix carcinoma, and metastatic breast carcinoma), one patient with breast carcinoma could not be considered evaluable for response because she had undergone radical mastectomy and had no measurable disease at the beginning of treatment with AS2-1; the cervical cancer patient had received prior radiation therapy, which could not be ruled out as producing a beneficial effect.
Partial remissions were reported in two cases, one each of stage III lung adenocarcinoma and chronic myelogenous leukemia in blastic phase. The patient with lung cancer had received prior radiation therapy; both patients developed disease progression and had died by the time of study publication. Seven cases were reported as having stable disease, and six patients had disease progression. Ten patients discontinued antineoplaston therapy during the study: two who were in complete remission, one in partial remission, and seven with stable disease.
Antineoplastons A10 and AS2-1
A 1998 case series from Japan discussed three patients enrolled in a phase I study of antineoplastons A10 and AS2-1. Diagnoses included one case of breast cancer metastatic to the lung, one case of an anaplastic astrocytoma/thalamic glioma, and one case of large cell lung carcinoma (stage IIIB). All patients also received chemotherapy and radiation therapy.