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Spots Global Cancer Trial Database for Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG)

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 6 Months

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Eric Bouffet, MD

Affiliation: The Hospital for Sick Children

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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