Experiment 838300

Details

PropertyValue
Pharmacology
Administration routeIV
OrganismEmpty organism
CitationLEGHA,SS: KEATING,M: PICKET,S: AJANI,JA: EWER,M: BODEY,GP:. (1984). PHASE I CLINICAL INVESTIGATION OF HOMOHARRINGTONINE.. 68(9)
Amount utilized
Compound isolated
DiseaseIN THIS PHASE I CLINICAL TRIAL,43 PATIENTS WITH REFRACTORY MALIGNANCIES WERE TREATED DAILY FOR 5 DAYS AT 3-4 WK INTERVALS. DOSE LIMITING TOXICITY WAS HYPOTENSION,WITH MILD TOXICITY SEEN AT 3-4.5 MG/SQ.M/DAY AND CARDIOVASCULAR COLLAPSE AT 5-6 MG/SQ.M. MODERATELY SEVERE MYELOSUPPRESSION WAS SEEN AT DOSES OF 3.0 MG/SQ.M. AND HIGHER,AND WAS CLEARLY RELATED TO THE EXTENT OF PRIOR TREATMENT. 2/3 OF THE PATIENTS EXPERIENCED MILD,SELF LIMITING GASTROINTESTINAL SYMPTOMS. NO MAJOR RESPONSES WERE OBSERVED. MINOR RESPONSES WERE SEEN IN 3 OF 5 PATIENTS WITH SEVERE LEUKEMIA AND IN 3 PATIENTS WITH SOLID TUMORS. SUGGESTED DOSNIG SCHEDULES FOR PHASE II STUDIES ARE 3 MG/SQ.M. FOR 5 DAYS IN PATIENTS WITH EXTENSIVE PRETREATMENT, AND 4 MG/SQ.M. FOR 5 DAYS IN PATIENTS WITH GOOD BONE MARROW RESERVE.
Dose amount0.2-8 MG
Number1
Qualitative resultEQUIVOCAL
AnimalHUMAN ADULT
Per unitSQ M BODY SURFACE
Dose expressionDOSE