Experiment 1171807

Details

PropertyValue
Pharmacology
Administration routeIV INFUSION
OrganismEmpty organism
CitationEINZIG,AI: GRALLA,RJ: LEYLAND-JONES,BR: KELSEN,DP: CIBAS,I: LEWIS,E: GREENBERG,E:. (1985). PHASE I STUDY OF ELLIPTINIUM (2-N-METHYL-9-HYDROXYELLIPTICINIUM).. 3(3)
Amount utilized
Compound isolated
DiseaseIN THIS PHASE I STUDY,33 PATIENTS WITH MALIGNANT NEOPLASM WERE TREATED WITH ELLIPTINIUM. THE INITIAL DOSE OF 40 MG/SQ.M.WAS ESCALATED OVER 6 STEPS TO 150 MG/SQ.M. THE INFUSION WERE GIVEN OVER 2 HRS WKLY FOR 4 WKS AND REPEATED AFTER A 2 WK REST PERIOD 29 PATIENTS WERE AVALUABLE FOR RESPONSE.THERE WERE PARTIAL RESPONSES IN ONE PATIENT EACH WITH HODGKIN'S DISEASE,NON-HODGKIN'S LYMPHOMA,BREAST CANCER,AND NASOPPHARYNGEAL CARCINOMA. RESPONSES LASTED 2 OR 3 MONTHS. MYELOSUPPRESSION WAS RARE, AND WAS NOT CLEARLY DOSE RELATED. ANTI-ELLIPTINIUM ANTIBODIES WERE FOUND IN 5 PATIENTS. NO EVIDENCE OF HEMOLYSIS WAS OBSERVED.MAJOR DOSE LIMITING TOXIC EFFECTS WERE XEROSTEMIA, EMESIS, AND AZOTEMIA. THESE TOXIC EFFECTS WERE MORE FREQUENT AND SEVERE AT DOSES OVER 80 MG/SQ.M.SOME NEPHROTOXICITY,AS EVIDENCED BY RAISED SERUM CREATIINE LEVELS 2 OF 8 PATIENTS WERE SEEN AT LEVELS ABOVE 100 MG/SQ.M. THIS DISAPPEARED AFTER TREATMENT WAS DISCONTINUED. THE RECOMMENDED DOSE FOR PHASE II EVALUATION IS 100 MG/SQ.M.ON A WEEKLY SCHEDULE.
Dose amountVAR
Number1
Qualitative resultEQUIVOCAL
AnimalHUMAN ADULT
Dose expressionDOSE