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NCT Number: NCT00213278

Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.

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Key information

Conditions

Glioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

1 day–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • < 21 years of age at original diagnosis
  • histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
  • evidence of tumor recurrence or progression by MRI or contrast CT
  • Karnofsky and Lansky performance status of 0,1 or 2
  • life expectancy of greater than or equal to 2 months
  • adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
  • absolute neutrophil count (ANC)> 1000/uL
  • platelet count > 100,000/uL (transfusion independent)
  • serum creatinine < 1.5 x normal for age
  • written informed consent signed by subject and/or subject's parent/legal guardian

Exclusion criteria

  • not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
  • chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
  • less than 7 days since the completion of therapy with a biologic agent
  • less than 2 months since cranial/spinal radiation
  • receiving a stable dose of dexamethasone for less than one week

Treatment and study plan

vinblastine sulphate injection

Drug

Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.

Primary outcomes

  1. To determine the response rate to Vinblastine in recurrent low grade glioma of childhood

    Time frame: 52 weeks

Secondary outcomes

  1. To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Ontario Cancer Research Network

Registry information

Official study title

A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma

Important dates

Study start
2002
Primary completion
2011
Study completion
2012
First posted
Sep 21, 2005
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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