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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
given intrathecally in induction phase every 15 days until CSF response for up to 7 injections. Then it is given every 4 weeks during consolidation phase while patient awaiting bone marrow transplant. For those patients who are not candidates for a bone marrow transplant, the drug will be given every 3 months for 4 administrations (maintenance therapy)
P.O. Gaspare Rodolico
Catania, Italy
Istituto G. Gasilini
Genova, Italy
Ospedale S. Gerardo Clinica Pediatrica
Monza, Italy
AORN Santobon - Pauslipon
Naples, Italy
number of cerebrospinal fluid (CSF) responses
Time frame: from two weeks after date of patient registration until the date of second consecutive cerebrospinal fluid exam that is negative for malignant cells, up to 12 weeks
number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02
Time frame: assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks
time to reaching CSF response
date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF
Time frame: date of patient registration to date of CSF response, up to 12 weeks
duration of CSF response
duration of response is the length of time in days from the date of the CSF response to the date of the first positive cytomorphologic CSF exam
Time frame: up to 12 months
worst grade non neurologic Adverse event during induction, according to CTCAE 4.02
Time frame: up to 12 weeks
worst grade toxicity after induction therapy according to CTCAE 4.02
Measured from date of CSF response
Time frame: up to 12 months
overall survival
Time frame: one year
time from patient registration to progression of disease in non CNS site
Time frame: up to one year
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A.O. Università Padova
Padova, Italy
ARNAS Osp Civico di Cristina
Palermo, Italy
IRCCS Ospedale Bambino Gesu'
Roma, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia
Trieste, Italy
Ospedale Policlinico G.B. Rossi
Verona, Italy
concentration of study drug present in CSF at each induction therapy
Time frame: prior to each induction therapy at 15 day intervals for up to 6 cycles
correlation of activity and toxicity with residual study drug level in CSF during induction
Time frame: measured at 15 day intervals for up to 6 cycles