Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Lymphoblastic Leukemia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of cerebrospinal fluid (CSF) responses

Outcome 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

Safety Issue:

No

Principal Investigator

Rosanna Parasole, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Santobono - Pausilipon Hospital

Authority:

Italy: Ethics Committee

Study ID:

CILI

NCT ID:

NCT01593488

Start Date:

March 2012

Completion Date:

July 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • recurrent
  • CNS disease
  • intrathecal therapy
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location