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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., 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
...and 11 more locations
Efficacy of the addition of Bevacizumab to Vinblastine compared with Vinblastine alone in chemotherapy-naïve pediatric patients with unresectable or progressive Low Grade Gliomas as measured by Response Rate (RR).
Objective response rate within 6 months of randomisation
Time frame: 6 months from randomization
Overall survival (OS) at the end of study.
overal survival at 5 years post randomisation
Time frame: From the date of study completion (approximately 6.5 years (78 months)) up till the date of death.
To determine 6 month, 12 month and 2 year progression free survival (PFS) between vinblastine alone versus in combination with Bevacizumab.
Optical Coherence Tomography (OCT) should occur in conjunction with the Visual Field/Acuity exams for participating institutions equipped with OCT.
Time frame: At 6 and 12 months and 2 years
To evaluate the difference in visual outcome measures in children with optic pathway gliomas treated with vinblastine alone or in combination with Bevacizumab.
visual acuity measure with Teller Grading Acuity
Time frame: Every 3 months during treatment, every 3 months for 1 year after completion of treatment, then every 6 months for 4 years.
To determine if the prevalence of cognitive deficits in children and adolescents treated for LGG, is significantly higher than the normative population (> 14%) using the NIH Toolbox Cognitive Battery.
Domains include: working memory, executive function, processing speed, episodic memory, and attention
Time frame: At 1 year off therapy
To determine the effects of Bevacizumab on cognitive function in the pediatric population using the NIH Toolbox Cognitive Battery.
The effects of Bevacizumab on cognitive function in the pediatric
Time frame: During treatment, 28 days after completing treatment, at 6 months and 1 year off therapy
To determine if the prevalence of QOL difficulties in children and adolescents treated for LGG at 1 year off therapy, is significantly higher than the normative population (> 14%).
Domains include: fatigue, physical activity, anxiety, depression, and peer relationships.
Time frame: At 1 year off therapy
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