Clinical Trial Details
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NCT01269424 : O6-Benzylguanine and Temozolomide With MGMTP140K Genetically Modified Blood Stem Cells in Untreated Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

- Patients with histologically confirmed, newly diagnosed, supratentorial GBM who have
undergone gross total tumor resections or near gross total resection (resection of
>90% of enhancing tumor demonstrated by MRI) are eligible up to their third
post-operative week. Patients with infratentorial disease, multifocal or
leptomeningeal disease will be excluded. In general, patients will not have > 1 cm
residual measurable or evaluable disease after surgical tumor resection.

- ECOG performance status 0-2 or Karnofsky ? 70.

- Patients must have received no myelosuppressive chemotherapy prior to the diagnosis
of GBM.

- Life expectancy of at least 12 weeks.

- Adequate hematologic (ANC ? 1,000/mm3, platelets ? 100,000/mm3, Hgb ? 9.5 , hepatic
(Bilirubin ? 2.0 mg/dl, AST and ALT less than or equal to 3 times upper limit of
normal, prothrombin time <1.2 times normal), and renal (Serum creatinine ? 2.0 mg/dl
or Creatinine Clearance ? 60mL/min/1.73 m2 for subjects with serum creatinine levels
above institutional normal) . These tests will be repeated within 2 weeks of
treatment with BG and TMZ, and must meet the same criteria.

- EKG without evidence of acute cardiac disease.

- Left ventricular ejection fraction (LVEF) ? 40

- Post-operative steroids are tapered to ? 24 mg decadron/d

- Patients of child-bearing potential must be using single barrier contraception

- Willingness and ability to provide informed consent.

- Patient must have all sutures removed prior to registration

- Patient must be considered to be clinically stable.

Exclusion criteria:

- Medical condition associated with immunosuppression, active infection or medical
illness which may jeopardize patient safety.

- HIV seropositivity. This exclusion is included for two reasons. First, there is
evidence of decreased marrow reserve in HIV+ patients and antiviral treatment is
associated with myelosuppression. Thus, drug treatment designed to be
myelosuppressive may be more toxic in this patient population. Second, extensive
laboratory culturing of the bone marrow and peripheral blood progenitor cells is
required. No preclinical samples which are HIV+ have been evaluated with the gene
transfer modality proposed and thus the feasibility and safety of gene transfer and
selection in HIV+ samples cannot yet be advocated. Such studies are planned so as to
not preclude HIV+ patients in later studies.

- Pregnant or lactating women. There is data to indicate that TMZ is teratogenic and
carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the

- Patients with symptomatic pulmonary disease and other severe co-morbid conditions

- Patients with cardiac insufficiency and an LVEF of < 40%. History of acute coronary
event disease or arrhythmia within 6 months prior to enrollment

- Prior chemotherapy (including gliadel wafers) or hematopoietic cell transplantation.

- Inability to undergo repeated MRI evaluation.

- Prior diagnosis of malignant disease within a three year period with the exception of
surgically cured basal cell carcinoma or carcinoma in situ of the cervix

- Mental incapacity or psychiatric illness preventing informed consent
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