Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children

Multicentered Phase II Study Evaluating the Activity and Toxicity of Liposomal Cytarabine in the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia With Resistent or Relapsed Central Nervous System Involvement

The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.

Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of ALL. This formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. This allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.

Inclusion Criteria:

• Age < 18 years
• Diagnosis of acute lymphoblastic leukemia (ALL)
• Central nervous system involvement with malignant cells present in cerebrospinal fluid
• CNS involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence
• CNS involvement may be an isolated lesion or present with other sites of disease
• ECOG performance status 0-2
• Life expectancy of at least 8 weeks
• Absence of severe organ dysfunction
• Informed consent

Exclusion Criteria:

• Eligibility for AIEOP studies of first recurrence of ALL,and receiving therapy in a center participating in the AIEOP studies
• Concurrent treatment with experimental therapies
• Severe neurologic toxicities from previous chemotherapy
• Severe coagulopathy at time of recurrence
• Sepsis
• Intrathecal therapy within 1 week of planned study therapy
• Total body or head and spine radiation within 8 weeks of enrolment
• Bone marrow transplant within 8 weeks of start of study therapy.