drugset / Trial / NCT00004217
S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs. PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.
Timeline
- Start
- 2000-02
- Primary completion
- 2001-05
- Completion
- 2006-03
Publications
- Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
- Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Daunorubicin | Small molecule | — | Intravenous |
| Subject | valspodar | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Background | sargramostim | Protein / enzyme biologic | 5 ug/kg | Intravenous |