Toxicology studies on antineoplaston AS2-5 injections in cancer patients.

Antineoplaston AS2-5 is one of the degradation products of Antineoplaston A10. The chemical structure of Antineoplaston AS2-5 corresponds to phenylacetylglutamine. Toxicology studies of Antineoplaston AS2-5 injections involved 13 patients diagnosed with 15 types of neoplastic disease, including: lung cancer, 3 cases; breast, 3 cases; colon, 2 cases; and single cases of cancer of the larynx, prostate, stomach, pancreas, malignant fibrohistiocytoma, embryonal teratoma and lymphocytic lymphoma. Antineoplaston AS2-5 was injected i.v. daily through subclavian vein catheter in divided doses. The treatment was administered from 41 to 436 days. The highest dosage given was 167.6 mg/kg/24 h. The treatment was associated with only very mild side-effects, including febrile reaction in two patients and swelling of small joints in one patient. Two patients had beneficial side-effects, including increase of platelet count and increase of concentration of plasma globulin. The treatment resulted in two complete remissions, one mixed response, four cases of stabilization and six cases of increasing disease. Complete remission was achieved in squamous cell carcinoma of the larynx, stage II, and large cell undifferentiated carcinoma of the lung with lymph nodes and liver metastases. One patient had mixed response during the treatment of carcinoma of the breast with metastases to the lymph nodes, liver and skin and obtained complete remission of liver metastases but increasing disease of skin metastases. Eight patients discontinued the treatment and three patients died during the trials. The patient diagnosed with lung cancer who obtained complete remission continues to be free from the disease over 5 years after the beginning of the treatment.(ABSTRACT TRUNCATED AT 250 WORDS)