Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas
Condition: Juvenile Pilocytic Astrocytomas; Optic Pathway Gliomas
MeSH terms: Glioma; Astrocytoma; Optic Nerve Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study of the drug, pegylated interferon alfa-2b (PEG-Intron), used to
      treat brain tumors in a pediatric population. Researchers want to see if treatment with
      PEG-Intron will stop tumor growth for patients with juvenile pilocytic astrocytomas or optic
      pathway gliomas.

      The purposes of this study are:

        -  To learn more about the response to pegylated interferon

        -  To learn more about the side effects of pegylated interferon

        -  To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or Optic
           Pathway Gliomas.

        -  To learn more about quality of life in patients treated with pegylated interferon
    

Detailed description: 
      Low grade gliomas are the most common pediatric central nervous system malignancies and can
      occur in different parts of the brain. Patients who undergo gross total resection, usually
      those with hemispheric tumors, have an excellent prognosis with surgical resection alone.
      Patients for whom gross total resection is not achievable have a significant risk of disease
      progression. Therefore, these patients benefit from adjuvant therapy. Multiple chemotherapy
      regimens have shown some efficacy in residual tumor, but more than 50% of patients experience
      recurrences. Radiation has been shown to be an effective therapy in the treatment of these
      tumors. Because of concerns regarding radiation toxicity especially in young children, and
      progression despite chemotherapy, novel approaches are needed. This protocol represents an
      attempt to measure the efficacy and safety of use of pegylated interferon for patients with
      recurrent, refractory Juvenile Pilocytic Astrocytomas (JPA) or optic pathway gliomas. It
      provides a different approach to the commonly used treatment modalities. The objectives of
      this study are to determine the response of children with chemotherapy-refractory progressive
      JPA or optic pathway gliomas (OPG) to weekly pegylated interferon alpha-2b. The secondary
      objectives include to better identify the toxicities of weekly pegylated interferon alpha-2b
      (PEG-Intron™) in pediatric patients with unresectable, refractory, recurrent JPAs or optic
      pathway gliomas, to evaluate various magnetic resonance imaging techniques for noninvasive
      monitoring of metabolic and biologic changes in the tumors and to evaluate the quality of
      life for patients with recurrent, refractory JPAs who receive therapy with pegylated
      interferon alpha-2b (PEG-Intron™).

      The primary end point is to determine the response rate. A two-stage design has been selected
      to evaluate the response rate. If the treatment demonstrates at least a 25% response rate,
      the researchers would consider it a promising regimen for further study. A response rate less
      than 5% is considered evidence of unpromising regimen. Seventeen evaluable pediatric patients
      with JPA or OPG will be accrued. If at least 3 responders are seen among the 17 patients,
      this will be considered evidence of a promising response rate for further evaluation.
    

Intervention name(s): Pegylated interferon alpha-2b
Intervention type(s): Drug
Intervention description(s): PEG-Intron 1mcg/kg/dose weekly through an injection under the skin on the same day each week
Other intervention name(s): Peg-Intron
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment