Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas

Not Applicable

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00253487
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. O6-benzylguanine may also help temozolomide work better by making ...

Detailed Description

OBJECTIVES:

Primary

* Determine the safety and feasibility of a conditioning regimen comprising temozolomide, radiotherapy, and busulfan followed by an infusion of autologous stem cells genetically modified with the MGMT gene and temozolomide and O6-benzylguanine in younger patients with newly diagnosed high-grade gliomas.

Secondary
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Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Status Verified: 2006-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified