Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Condition: Low-grade Glioma
MeSH terms: Glioma
Intervention: Vinorelbine
Intervention description: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Intervention MeSH terms: Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: pediatric; children; glioma; low-grade; vinorelbine; recurrent; progressive

Summary:

      The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink
      or slow the growth of pediatric low-grade gliomas that have either returned or are continuing
      to grow.

      Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in
      patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its
      therapeutic spectrum and decrease the neurotoxicity associated with related agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: < 18 years

          -  Tumor: Progressive or recurrent low grade glioma, WHO grade 1 or 2 who have failed at
             least one form of 'conventional' non-surgical therapy

          -  Histologic confirmation is required with the exception of optic pathway and brain stem
             gliomas. Patients are not required to have a re-operation at time of recurrence.

          -  Patients with disseminated disease are eligible.

          -  Children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible
             but must have definitive radiologic or clinical evidence of progression

          -  Patients must have evidence of measureable disease

          -  Performance status: Karnofsky or Lansky performance status of >50%

          -  Organ Function:

          -  Adequate bone marrow function (ANC>1000/mm3, platelet count of >75,000/mm3, and
             hemoglobin > 8gm/dL) prior to starting therapy. Hemoglobin may be supported by
             transfusion

          -  Adequate liver function (SGPT/ALT<2.5 times ULN and bilirubin < 1.5 times ULN) prior
             to starting therapy

          -  Prior therapy:

          -  May have had treatment including surgery, chemotherapy, or radiotherapy for any number
             of relapses prior to enrollment

          -  Patients must have received their last fraction of radiotherapy >12 weeks prior to
             starting therapy

          -  Previous Vincristine or Vinblastine exposure is allowable.

        Exclusion Criteria:

          -  No other significant medical illness that in the investigators' opinion cannot be
             adequately controlled with appropriate therapy or would compromise the patient's
             ability to tolerate this therapy

          -  Any other cancer (except non-melanoma skin cancer), unless in complete remission and
             off of all therapy for that disease for a minimum of 3 years.

          -  Patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine
             is a pregnancy category D, no data on excretion in breastmilk)

          -  Patients of childbearing or fathering potential must practice adequate contraception