NCT00936156

Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.

Conditions

• Metastatic, Cerebral Primitive Neuroectodermal Tumors

Interventions

Type	Name	Description
DRUG	Chemotherapy (carboplatin, etoposide, thiotepa)	Conventional chemotherapy: carboplatin injection (160 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Etoposide injection (100 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Double intensification by high-dose chemotherapy followed by autologous PBSC rescue: thiotepa injection (200 mg/m²/day as an infusion over one hour in 200 ml/m² of 5 % GS) administered from D42 to D44 and from D63 to D65. Autologous PBSC rescue on D47 and D68. Surgical resection of any tumor residue. Irradiation of the primary tumor site and cerebrospinal axis: 54 Gy to primary tumor, 36 Gy to cerebrospinal axis. Maintenance treatment: Temozolomide 150 mg/m²/day orally for 5 days every 28 days, from 1 month after the end of irradiation. 6 cycles planned. Duration of treatment: 13 months

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-07-09
• Last updated: 2020-06-29

Locations

1 site across 1 country: France