Antineoplastons (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies
In 1987, 24 patients with 25 various malignancies participated in a retrospective nonconsecutive case series study of antineoplaston A3. Patients who had more than 6 weeks' anticipated survival and who continued the treatment for more than 6 weeks were eligible. Antineoplaston A3 was administered through subclavian vein catheter in 23 patients. One patient received IM injections. Length of treatment was 44 to 478 days. Side effects, which occurred only once during treatment, included fever and chills in four patients, vertigo in two patients, headache in two patients, flushing of the face in one patient, nausea in one patient, and tachycardia in one patient. In addition, there was an increase in platelets, white blood cell counts, and reticulocyte counts. Tumor response was complete in five patients, and partial response was seen in five patients. Stable disease was reported in nine patients, while six patients had disease progression. One patient received radiation therapy before entering the study, so tumor response cannot be attributed solely to A3. Six patients discontinued treatment during the study; no reasons were reported.
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.