NCT00179803

Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors

Phase II Prospective Study of Sequential Myeloablative Chemotherapy With Stem Cell Rescue for the Treatment of Selected High Risk CNS Tumors and Recurrent CNS Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 18 Months – 25 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this study is to determine if a stem cell transplant in patients with newly diagnosed high risk CNS tumors (glioblastoma multiforme \[GBM\], high grade astrocytoma, pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor \[PNET\]) increases overall survival.

Conditions

• Glioblastoma
• Astrocytoma
• Pineoblastoma
• Rhabdoid Tumor
• Supratentorial Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Stem Cell Transplant	Group A: recurrent medulloblastoma, recurrent germ cell tumor * Cytoxan treatment * Stem cell autologous harvest Group B: GBM, high grade astrocytoma, rhabdoid tumors, pineoblastoma, or supratentorial PNET * Carboplatin and Etoposide treatment * Autologous stem cell harvest The preparatory regimen used for Stem Cell Rescue #1 will be Carboplatinum, VP-16 and Thiotepa. If the patient has recuperated his ANC to \>1,000 within 50 days after Stem Cell Rescue #1, (sustained without G-CSF support) a neuroradiographic evaluation will be performed. If there is lack of progression, the patient will then proceed to Stem Cell Rescue # 2 with Cyclophosphamide and Melphalan, followed by stem cell rescue.

Timeline

• Start date: 1998-03-01
• Primary completion: 2008-01-01
• Completion: 2009-09-01
• First posted: 2005-09-16
• Last updated: 2020-08-05

Locations

1 site across 1 country: United States