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A Phase I Study of Clofarabine Plus Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients with Relapsed or Refractory Acute Leukemia

[Protocol 07-012]

Full Title :

A PHASE I DOSE ESCALATION TRIAL OF CLOFARABINE IN ADDITION TO TOPOTECAN, VINORELBINE, THIOTEPA, AND DEXAMETHASONE IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY ACUTE LEUKEMIA

Purpose :

Clofarabine is a drug that was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed acute lymphoblastic leukemia. The purpose of this study is to determine the highest safe dose of clofarabine that can be given in combination with four other chemotherapy drugs -- topotecan, vinorelbine, thiotepa, and dexamethasone -- in children with acute leukemia that has returned despite treatment or has stopped responding to standard therapies.

To speed the return of infection-fighting white blood cells (whose numbers are reduced by chemotherapy), patients will also receive granulocyte stimulating factor (G-CSF) after chemotherapy.

Eligibility :

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

• Patients must have a confirmed diagnosis of acute lymphoblastic leukemia or acute myelocytic leukemia that has returned despite treatment or has stopped responding to standard therapies.
• At least 2 weeks must have passed since completion of prior chemotherapy and entry into the study. Patients may not have previously received clofarabine.
• Patients must be under age 21.

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