Clinical Trial Details
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NCT01497860 : Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
PhasePhase 2
AgesMin: N/A Max: 18 Years
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

- 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
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