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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: To determine if the use of sequential myeloablative chemotherapy with peripheral blood stem cell rescue will increase the overall survival rate in patients with newly diagnosed high risk CNS tumors [ Time Frame: To end of study ]

Original Primary Outcome: To determine if the use of sequential myeloablative chemotherapy with peripheral blood stem cell stem cell rescue will increase the overall survival rate in patients with newly diagnosed high risk CNS tumors (GBM, high grade astrocytoma, pineoblastoma

Current Secondary Outcome:

  • The overall survival and progression free survival in children with recurrent CNS malignancies after obtaining a state of minimum residual disease with submyeloablative chemotherapy, surgery, and/or radiation. [ Time Frame: To end of study ]
  • To determine the progression free survival and overall survival using sequential myeloablative chemotherapy as compared to historical controls with single autologous stem cell rescue following myeloablative chemotherapy. [ Time Frame: To end of study ]
  • Determine the long term neurocognitive, endocrinologic, cardiopulmonary, and hematologic sequelae of sequential myeloablative chemotherapy and stem cell rescues in patients treated for high risk CNS and recurrent CNS tumors. [ Time Frame: To end of study ]
  • Determine the feasibility and utility of the myeloablative preparatory regimen of Carboplatinum, VP-16 and Thiotepa administered in an outpatient setting, and to determine the cost savings obtained via this strategy. [ Time Frame: To end of study ]


Original Secondary Outcome:

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: September 10, 2005
Date Started: March 1998
Date Completion:
Last Updated: March 10, 2011
Last Verified: March 2011