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A Phase I/II Study of Clofarabine in Combination with Etoposide and Cyclophosphamide in Pediatric Patients with Refractory or Relapsed Acute Leukemia

[Protocol 07-039]

Full Title :
A PHASE 1/2 DOSE-ESCALATION STUDY OF CLOFARABINE IN COMBINATION WITH ETOPOSIDE AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH REFRACTORY OR RELAPSED ACUTE LEUKEMIA (CL021800205)
Purpose :

The purpose of this study is to evaluate the safety and effectiveness of combining three anticancer drugs -- clofarabine, etoposide, and cyclophosphamide -- for the treatment of pediatric patients with acute leukemia that does not respond to standard therapies or has returned despite therapy.

Clofarabine is a drug approved for treating children (ages 1 to 21) with leukemia. Cyclophosphamide and etoposide can be used with other anticancer drugs as a treatment for leukemia. Before this research study, these three drugs had not been used together.

The purpose of the phase I portion of this study is to find the highest doses of clofarabine, etoposide, and cyclophosphamide that can be given safely together in children with acute leukemia that has persisted or recurred. The purpose of the phase II portion of the study is to determine the effectiveness of this drug trio against these types of cancer.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be between the ages of 1 and 21.
  • Patients must have a confirmed diagnosis of acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) that does not respond to standard therapies or has returned despite therapy.
  • Patients may not have had more than one stem cell transplant.
  • Patients with AML may not have had more than two prior induction regimens and those with ALL may not have had more than three prior induction regimens.
  • Patients may not have previously received clofarabine.

For more information or to inquire about eligibility for this study, please contact Dr. Peter Steinherz at 212-639-7951.

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