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hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM Study

Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis

brain scan
AGE: 18+ years
SEX AT BIRTH: All
TYPE: Interventional Treatment
HEALTHY PARTICIPANTS: No
CONDITION: Glioblastoma Multiforme (GBM)
LOCATION: University Hospitals Medical Centers

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Purpose of Study

The purpose of this study is to see if introducing the gene mutation called P140K MGMT into hematopoietic stem cells (HSC) taken from patients such as yourself combined with aggressive chemotherapy, including high doses of TMZ and BG, will protect your bone marrow but also allow the residual tumor cells to be killed. Stem cells play a key role in growth, repair and renewal. Stem cells have the ability to become specialized cells in the body including red blood cells (the cells that carry oxygen), platelets (the cells that help stop bleeding) and white blood cells (the cells that fight infections).

This study will also look at the side effects of P140K MGMT engineered HSC, and whether the cells containing the P140K MGMT help to protect you from the side effects of BG and TMZ chemotherapy. The study will also determine how much TMZ can be given with BG in patients who have cells with the P140K MGMT gene inserted. Approximately 16 subjects will take part in this study.

Who Can Participate?

Participants 18 years of age or older diagnosed with glioblastoma multiforme may be eligible for this study.

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