T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650)
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 (VePesidŽ, VP-16) and cyclophosphamide (CytoxanŽ). 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.
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 : etoposide
- drug : cytarabine
- drug : filgrastim
- drug : cyclophosphamide
Phase: Phase 2
Ages Eligible For Study:
- Age: patients must be ? 1 and ? 21 years of age at the of study entry. - Diagnosis: - Patients must have a diagnosis of first or second relapse or refractory acute myelogenous leukemia (AML) according to WHO classification with ? 5% blasts in the bone marrow, with or without extramedullary disease. (See Appendix I) - Patients may have CNS 1 or CNS 2 disease but not CNS 3. - Performance Level: Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ? 16 years of age. - Prior Therapy: - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. - Patient has not received more than 2 previous induction attempts. (Frontline therapy is included in this count). - Patients must have adequate venous access. - At least 1 year must have elapsed since hematopoietic stem cell transplant (HSCT) and patients must not have active GVHD. - Reproductive Function - Female patients of childbearing potential must have a negative serum pregnancy test confirmed within 2 weeks prior to enrollment. - Female patients with infants must agree not to breastfeed their infants while on this study. - Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment. - Renal and Hepatic Function: Patient must have adequate renal and hepatic functions as indicated by the following laboratory values: - Patients must have a normal calculated creatinine clearance. - Total bilirubin <1.5 x ULN for age and conjugated/direct serum bilirubin ? ULN for age if total bilirubin is elevated. - Aspartate transaminase (AST)/alanine transaminase (ALT) ? 2.5 × ULN. - Alkaline phosphatase ? 2.5 × ULN. - Informed Consent: Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent. - Protocol Approval: All institutional, FDA, and OHRP requirements for human studies must be met.