drugset / Trial / NCT00002912
Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia
NaSingle-groupOpen-labelTreatment
Summary
Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in treating children who have refractory or relapsed acute leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may reduce resistance to the drug and allow more cancer cells to be killed.
Timeline
- Start
- 1997-01
- Primary completion
- 2006-03
- Completion
- —
Publications
- Results O'Brien MM, Lacayo NJ, Lum BL, Kshirsagar S, Buck S, Ravindranath Y, Bernstein M, Weinstein H, Chang MN, Arceci RJ, Sikic BI, Dahl GV. Phase I study of valspodar (PSC-833) with mitoxantrone and etoposide in refractory and relapsed pediatric acute leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 May;54(5):694-702. doi: 10.1002/pbc.22366.
- Results Lacayo NJ, Lum BL, Chin DL, et al.: Pharmacokinetics of mitoxantrone in a Phase I Trial of PSC-833 (Valspodar) as an MDR1/Pg-P modulator in acute myeloid leukemia (AML) from the children's oncology group (COG). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1583, 2002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etoposide | Small molecule | — | Intravenous |
| Subject | Mitoxantrone | Small molecule | — | Intravenous |
| Subject | valspodar | Protein / enzyme biologic | 8 mg/kg | Intravenous |
| Subject | valspodar | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | valspodar | Protein / enzyme biologic | 12.5 mg/kg | Intravenous |
| Subject | valspodar | Protein / enzyme biologic | 15 mg/kg | Intravenous |