Experiment 635747

Details

PropertyValue
Pharmacology
Administration routeIV
OrganismEmpty organism
CitationWEITMAN,S: LANGEVIN,AM: BERKOW,RL: THOMAS,PJ: HURWITZ,CA: KRAFT,AS: DUBOWY,RL: SMITH,DL: BERNSTEIN,M:. (1999). A PHASE I TRAIL OF BRYOSTATIN-1 IN CHILDREN WITH REFRACTORY SOLID TUMORS: A PEDIATRIC ONCOLOGY GROUP STUDY.. 5(9)
Amount utilized
Compound isolated
DiseaseA 1-HR INFUSION OF BRYOSTATIN-1 IN A PET FORMULATION (60% POLYTHELENE GLYCOL 400, 30% ETHANOL, AND 10% TWEEN 80) WAS ADMINISTERED WEEKLY FOR 3 WEEKS TO 22 CHILDREN (AGE RANGE, 2-21 YEARS) WITH MALIGNANT SOLID TUMORS REFRACTORY TO DOSE. PHARMACOKINETICS WERE PERFORMED IN AT LEAST THREE PATIENTS PER DOSE LEVEL. THE FIRST COURSE WAS USED TO DETERMINE THE DLT AND MTD. THERE WAS NO PARTIAL OR COMPLETED RESPONSE TO BRYOSTATIN-1 ON THIS SCHEDULE. ONE PATIENT WITH RENAL CELL CARCINOMA HAD STABLE DISEASE THROUGH FOUR COURSES AND ONE WITH NEUROBLASTOMA SIMILARY RECEIVED TWO COURSES AT 20 MCG/M2. BOTH PATIENTS THEN ELECTED TO SEEK OTHER THERAPEUTIC OPTIONS. TWO PATIENTS (1 GERM CELL TUMOR, 34 MCG/M2 FOR FIVE COURSES; 1 RENAL CELL CARCINOMA, 34 MCG/M2 FOR THRE COURSE) WITH MICROSCOPIC DISEASE AT INITIATION OF BRYOSTATIN-1 WERE FREE OF PROGRESSION WHILE ON STUDY.
Dose amountVAR
Number1
Qualitative resultEQUIVOCAL
AnimalHUMAN CHILD
Dose expressionDOSE
GenderGIVEN TO BOTH SEXES