At a glance
ClinicalIndex Comparison Record- ✓Relapsed or progressive medulloblastoma (Stratum I)
- ✓Relapsed or progressive ependymoma with at least one site of untreated recurrent disease (Stratum II)
- ✓Relapsed or progressive ATRT with at least one site of untreated recurrent disease (Stratum III)
- ✓Relapsed or progressive medulloblastoma with at least one site of untreated recurrent disease (Stratum IV)
- ✕VP- or subdural peritoneal shunt dependency (except Stratum V)
- ✕Prior treatment with temozolomide/irinotecan (except Stratum V)
- ✕Active infection, pregnancy or breast feeding
- ✕Known hypersensitivity to any of the drugs in the protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
In Brief
A Phase 2 clinical trial evaluating Bevacizumab, Thalidomide, and 8 other interventions for Medulloblastoma Recurrent and 3 related conditions. Currently recruiting, targeting 232 participants across 22 sites in 8 countries.
Detailed Summary
Patients with with recurrent or progressive medulloblastoma, ependymoma, atypical teratoid rhabdoid tumor (ATRT), and CNS tumors of various histologies have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenesis therapy has emerged as a new treatment option in solid malignancies. The frequent delivery of low doses of chemotherapy, referred to as metronomic or antiangiogenic chemotherapy, targets endothelial cells while reducing the toxicity associated with standard dose chemotherapy. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma, ATRT, and CNS tumors of various histologies, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The study will be conducted in independent strata. Stratum I (recurrent medulloblastoma): recently completed (Peyrl, 2023). Stratum II (recurrent ependymoma), III (recurrent ATRT) and V (recurrent CNS tumors of various histologies, patients with exclusion criteria and adult patients): The primary objective is to determine the response rate defined as the percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or lack of recurrence at 6 months after start of antiangiogenic treatment. Stratum IV (recurrent medulloblastoma): To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt. Additionally, PFS, OS, toxicity, QoL, performance status, predictive and prognostic markers will be examined. In stratum II and III, the study will follow an open label, single arm phase 2 design, and an open label randomized two-arm phase 2 design in Stratum IV, and the exploratory Stratum V.
Study Details
Timeline
Interventions
10mg/kg, intravenous (iv), biweekly, 1 year
3mg/kg, oral, daily, 1 year
50-400mg, oral bid, daily, 1 year
90mg/m2, oral, daily, 1 year
35-50 mg/m2, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
2.5mg/kg, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
0.5mg, intrathecal, day 1-5, every four weeks, alternating with intrathecal liposomal cytarabine, 1 year
16-30mg, intrathecal, twice weekly for two weeks out of every four weeks, alternating with intrathecal etoposide phosphate, 1 year
Stratum IV; 150mg/m2, day 1-5 every four weeks
Stratum IV; 50mg/m2, day 1-5 every four weeks