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Brief Title: Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG)
Official Title: A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)
Study ID: NCT02840409
Brief Summary: This is an open-label, randomized, multi-center, comparator Phase II trial looking at the addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68 weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered every two weeks IV for the initial 24 weeks. Randomization will take place at the time of registration taking into account NF1 and BRAF-KIAA1549-fusion status.
Detailed Description:
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Women's and Children's Hospital, North Adelaide, South Australia, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Perth Children's Hospital, Nedlands, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Stollery Children's Hospital, Edmonton, Alberta, Canada
BC Children's Hospital, Vancouver, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
McMaster Children's Hospital, Hamilton, Ontario, Canada
Children's Hospital - London Health Sciences Centre, London, Ontario, Canada
The Hospital for Sick Children, Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montréal, Quebec, Canada
Montreal Children's Hospital, Montréal, Quebec, Canada
CHU du Quebec-Universite Laval, Québec, Quebec, Canada
Starship Children's Hospital, Grafton, Auckland, New Zealand
Name: Eric Bouffet, MD
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR