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		Treatment Name:		A Pilot Study of Temozolomide and 06Benzylguanine for Treatment of Newly Diagnosed High Grade Glioma, Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection

		Phase:		Phase 1

		Treatment ID#:		1702

		Age Group:		Adult And Pediatric

		Min Karnofsky Score:		50: Requires considerable assistance and frequent medical care

		Conditions:		Prior Surgery is Allowed Prior Radiation is Not Allowed Prior Chemotherapy is Not Allowed

		Last Updated:		05/01/2007

		Tumor Types:		Anaplastic Astrocytoma Glioblastoma Multiforme


		Comments:		The use of temozolomide (TEM) both during and after irradiation is a promising new approach for the treatment of patients with high-grade glioma. However, this treatment is limited by tumor cell resistance and therapy-related hematologic toxicity. To overcome TEM resistance, in this study we will add the chemotherapy sensitizing drug O6-Benzylguanine (BG). To overcome hematologic toxicity, patients will receive autologous hematopoietic stem cells transduced with a chemotherapy resistance gene designed to protect these cells from subsequent therapy with this drug combination. The potential benefit of using transduced blood stem cells is the possibility for dose escalation of TEM, since hematologic toxicity has heretofore limited higher doses. Transduction will be accomplished with a retroviral vector carrying MGMTP140K, which codes for a mutated form of the resistance protein methylguanine-DNA methyltransferase (MGMT). Successful transduction of hematopoietic cells with MGMTP140K makes them resistant to the toxic effects of both TEM + BG. Repeated doses of these drugs should therefore result in an increase in the percentage of transduced (and thus protected) blood stem cells, thus reducing the likelihood of hematologic toxicity with further therapy. Accordingly, patients who are tolerating therapy well and who have laboratory evidence of chemoprotection will receive intrapatient dose escalation of TEM + BG during courses 2-6.

		Treatment Type:		Chemotherapy Radiation Gene Therapy

		Contact:		Lars Wagner MD Cincinnati Childrens Hospital Medical Center Cincinnati , OH 45229 USA Phone: 513-636-1849 Fax: E-mail: Lars.Wagner@cchmc.org Website:

Last updated refers to the date when our listing for each treatment was last updated.
ID is a combination of our internal ID and the official ID for the trial, if any.
Min Karnofsky is a general guide to how well you have to function to use this treatment

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