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Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)

Phase 2
1 Year
18 Years
Open (Enrolling)

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Trial Information

Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)

Unresectable low grade glioma (LGG) of childhood increasingly appears as a chronic condition
for which multiple treatments may be required. While several studies have shown evidence of
short term tumour control with chemotherapy, the progression-free survival at 5 years is
unsatisfactory. In addition, several regimens currently used for this condition are
associated with significant risks of side effect and long term toxicity.

We have piloted in a single arm study the feasibility and efficacy of Vinblastine for
children with recurrent and refractory low grade glioma, who have failed at least one line
of treatment (chemotherapy and/or irradiation). Preliminary results show promising activity
with minimal toxicity.

Inclusion Criteria:

1. Patients must have been < 18 years of age when originally diagnosed.

2. Histologic Diagnosis: Patients must have histologic verification of LGG at original
diagnosis. Exceptions are optic pathway gliomas in children with neurofibromatosis or
children with large hypothalamic tumours for which a diagnostic biopsy does not
seem necessary. Patients with disseminated low grade glioma are eligible.

1. Astrocytoma Variants: fibrillary, protoplasmic, gemistocytic, mixed

2. Pilocytic Astrocytoma

3. Pleomorphic Xanthoastrocytoma

4. Infantile desmoplastic astrocytoma

5. Ganglioglioma

6. Oligodendroglioma

7. Mixed glioma (including oligo-astrocytoma)

8. Pilomyxoid astrocytoma

3. Performance Level :Patients must have an ECOG performance status of 0, 1 or 2 or a
Lansky/Karnofsky score > 50

4. Life expectancy: Patients must have a life expectancy of * 2 months.

5. Prior Therapy: Patients are eligible at the time of diagnosis or first progression
following treatment with surgery only.

6. Measurable Disease: Patients must have measurable disease, documented by
radiographic criteria.

7. Concomitant Medications

1. Steroids: Steroids may be used at the time of inclusion to control progressive

2. Anti-epileptic medications are permitted - levetiracetam (Keppra) or clobazam
(Frisium) being the preferred anti-epileptic medications for chronic use
reserving phenytoin and lorazepam for acute seizure control.

8. Organ Function Requirements: All patients must have adequate organ and bone marrow
function within 7 days of starting chemotherapy (ANC * 1.0 x 109/L /, and platelet
count * 100 x 109/L (transfusion independent).

9. Regulatory: All patients and/or their parents or legal guardians must sign a written
informed consent and all institutional requirements for human studies must be met.
This study is open to all participants regardless of gender or ethnicity.

Exclusion Criteria:

Inclusion criteria are restrictive. Patient must meet all inclusion criteria.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The response rate to weekly vinblastine

Outcome Time Frame:

70 Weeks

Safety Issue:


Principal Investigator

Eric Bouffet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children, Toronto Canada


Canada: Health Canada

Study ID:




Start Date:

October 2007

Completion Date:

October 2018

Related Keywords:

  • Glioma
  • pediatrics
  • Low Grade Glioma
  • Vinblastine
  • Glioma