Conditions: Relapsed Acute Myelogenous Leukemia
Keywords: relapsed relapse refractory AML Acute myelogenous leukemia Relapsed AML
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Detailed description:
Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

Arms:
arm 1: All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.

Interventions: intervention 1: Clofarabine intervention 2: Etoposide intervention 3: Cyclophosphamide intervention 4: Filgrastim intervention 5: Cytarabine
Intervention descriptions: intervention 1: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5. intervention 2: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5. intervention 3: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5. intervention 4: Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days. intervention 5: Given intrathecally on day 1 at the dose defined by age below:

30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age

Protocol document: