A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : clofarabine
- drug : Cyclophosphamide
- drug : Etoposide
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- NOTE: the following eligibility criteria were applicable to acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study). - ALL with > 25% blasts in bone marrow; AML with ? 5% blasts in bone marrow; ALL and AML patients may have extramedullary disease - Karnofsky Performance Status ? 50 for patients > 10 years old; Lansky Performance Status ? 50 for patients ? 10 years old - Prior therapy: AML: 1-2 prior induction regimens and ? 1 hematopoietic stem cell transplant (HSCT); ALL: 1-3 prior induction regimens - Adequate liver, renal, pancreatic, and cardiac function - Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)