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Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas

Phase 2
18 Years
Open (Enrolling)
Low-grade Glioma

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Trial Information

Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas

Different treatments exist for children with progressive or recurrent low-grade glioma.
Each has variable efficacy at slowing or reversing growth, and exploration continues into
finding better-tolerated, more effective treatments.

Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas.
It has been fairly well tolerated in both adult and pediatric studies that have examined
its use in other tumors.

In addition, the quality of life for children with low-grade gliomas is important and
requires further study. This trial will incorporate an optional assessment using validated
neuropsychological testing throughout treatment to evaluate the quality of life of the child
being treated.

Objective: To test the efficacy of Vinorelbine in a larger number of children with pediatric
low-grade glioma that has returned or continues to grow.

In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a
2 week rest. This cycle can then be repeated for up to 1-2 years if providing clinical

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or date off study. This will be assessed continually for 60 months.

Safety Issue:


Principal Investigator

Eugene Hwang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

July 2019

Related Keywords:

  • Low-grade Glioma
  • pediatric
  • children
  • glioma
  • low-grade
  • vinorelbine
  • recurrent
  • progressive
  • Glioma



Mayo Clinic Rochester, Minnesota  55905
Children's National Medical Center Washington, District of Columbia  20010-2970