Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG) (NCT02840409) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG)
United States109 participantsStarted 2016-08-01
Plain-language 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.
Who can participate
Age range6 Months – 18 Years
SexALL
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Inclusion criteria
✓. Children and adolescents aged 6 months to \< 18 years old with Low Grade Glioma (See Appendix I).
✓. All patients must submit tumour tissue (fresh tumour tissue is recommended) and have pathological confirmation of LGG and determination of BRAF characteristics from the Hospital for Sick Children. Exceptions will be made for patients with neurofibromatosis type 1 who have not previously had a biopsy. NF1 patients are eligible without tissue confirmation but must have definitive clinical or radiographic evidence of tumour progression or risk for significant neurologic deterioration requiring immediate therapy. If a tissue sample for NF1 patients is available from a previous biopsy, it is required to be submitted for Central Review at the Hospital for Sick Children. Please refer to the lab manual for further details.
✓. Patients must have progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (\< 95% or \> 1.0 cm2 residual tumour) with necessity to begin treatment because of a risk of neurological impairment with progression.
✓. All patients on study must have measurable tumour (\>1.0 cm2 of residual tissue if resection has been performed) within 28 days of enrollment.
✓. Patients must have received no prior therapy including chemotherapy, biological modifiers and/or radiation treatment for the tumour with the exception of surgery.
✓. Patient is able to start treatment within 14 working days after randomization.
What they're measuring
1
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).
✓. Post pubertal teenagers who are sexually active agree to use two methods of contraception during the treatment period and for at least 6 months after the last dose of study drug. Please refer to Appendix V for a list of acceptable methods of contraception.
✓. Lansky performance status \> 50% for patients \< 16 years of age. Karnofsky performance status \> 50% for patients ≥ 16 years of age.
Exclusion criteria
✕. Children under 6 months of age.
✕. Pregnant or lactating females.
✕. Use of any investigational agent, systemic, targeted or immunotherapy prior to the first dose of study treatment.
✕. Any bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation).
✕. Patients with evidence of new symptomatic CNS hemorrhage (\> grade I) on baseline MRI.
✕. Any significant cardiovascular disease, e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis, CVAs, transient ischemic attacks (TIAs), and systemic hypertension (i.e., a systolic and diastolic BP ≥ 95th percentile for age, sex), prior history of hypertensive crisis or hypertensive encephalopathy or stroke, uncontrolled cardiac arrhythmia within 6 months prior to enrollment .
✕. Any previous venous thromboembolism Grade 3 or higher (NCI CTCAE v. 4.03).
✕. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.