Experiment 1089678
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | IV |
| Organism | Empty organism |
| Citation | OHNUMA,T: SRIDHAR,KS: RATNER,LH: HOLLAND,JF:. (1982). PHASE 1 STUDY OF INDICINE N-OXIDE IN PATIENTS WITH ADVANCED CANCER.. 66() |
| Amount utilized | |
| Compound isolated | |
| Disease | A PHASE I STUDY IN 37 PATIENTS WITH SOLID TUMORS:15 MEN AND 22WOMEN(MEAN AGE,53 YEARS).ALL HAD PEVIOUS CHEMOTHERAPY AND 25 HAD HAD PRIOR RADIOTHERAPY. EIGHTY-FOUR PER CENT HAD A PERFORMANCE STATUS. OF 0-3 (CANCER AND LEUKEMIA GROUP B CRITERIA). THE DRUG WAS GIVEN AS A SHORT INFUSION OVER 15 MINUTES AND REPEATED WITH A MEDIAN INTERVAL OF 4 WEEKS.DOSES WERE ESCALATED FROM 1 TO 9 GM/SQ METER.A TOTAL OF 55 COURSES WERE EVALUABLE. DOSE-LIMITING TOXIC EFFECTS WERE LEUKOPENIA AND THROMBOCYTOPENIA. TOXICITY WAS CUMULATIVE WITH REPEATED DOSES. OTHER TOXIC EFFECTS INCLUDED NAUSEA AND VOMITING,ANEMIA AND HEPATIC DYSFUNCTION,POOR MARROW RESERVE AND HEAVY PRIOR CHEMOTHERAPY AND RADIOTHERAPY. THERE WERE NO COMPLETE OR PARTIAL RESPONSES. ONE PATIENT WITH SKIN MELANOMA AND ANOTHER WITH OVARIAN CARCINOMA HAD IMPROVEMENT LASTING TWO MONTHS. THE MAXIMALLY TOLERATED DOSE IS 9 GM/SM METER IN THIS STUDY. ARECOMMENDED DOSE FOR THERAPEUTIC STUDY IS 7 GM/SQ METER. HIGH RISK PATIENTS SHOULD BE STARTED AS A DOSE OF 5 GM/SQ METER. THE TREATMENT MAY BE REPEATED AT 4-WEEK INTERVALS WITH CLOSE MONITORING OF WBC AND PLATELET COUNTS. DOSE REDUCTIONS MAY BE NECESSARY. FOR REPEATED COURSES. |
| Dose amount | 7.0 GM |
| Number | 1 |
| Qualitative result | EQUIVOCAL |
| Animal | HUMAN ADULT |
| Per unit | SQ M BODY SURFACE |
| Dose expression | DOSE |
| Gender | GIVEN TO BOTH SEXES |