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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

number of cerebrospinal fluid (CSF) responses

Secondary Outcome

 time to reaching CSF response

Condition

Acute Lymphoblastic Leukemia

Intervention

liposomal cytarabine

Study Arms / Comparison Groups

 Intrathecal liposomal cytarabine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

March 2012

Completion Date

December 2017

Primary Completion Date

September 2017

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rosanna Parasole, M.D., +39 081 5903383, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01593488

Organization ID

CILI

Secondary IDs

2011-002622-48

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute, Naples

Collaborators

 Santobono-Pausilpon Hospital

Study Sponsor

Rosanna Parasole, M.D., Principal Investigator, Santobono - Pausilipon Hospital


Verification Date

March 2017