drugset / Trial / NCT00003190

Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia

NCT00003190

Phase 3 Completed 640 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs. Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells.

Timeline

Start
1998-01
Primary completion
2002-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject valspodar Protein / enzyme biologic Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous
Background Etoposide Small molecule Intravenous