Clinical Trial Details
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NCT00669669 : O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients with glioblastoma multiforme or gliosarcoma

- The patient or legal guardian must be able to comprehend the informed consent form
and sign prior to patient enrollment

- Karnofsky performance status at time of study entry must be >= 70%

- Life expectancy of >= 3 months

- Patients must agree to undergo repeat clinical neurological examinations and brain
magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of

- White blood cell (WBC) > 3000/ul

- Absolute neutrophil count (ANC) > 1500/ul

- Platelets > 100,000/ul

- Hemoglobin > 10 gm/100ml

- Total and direct bilirubin < 1.5 times upper limit of laboratory normal

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) =< 3 times upper limit of laboratory normal

- Alkaline phosphatase =< 3 times upper limit of laboratory normal

- Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal

- Serum creatinine < 1.5 times upper limit of laboratory normal

- Left ventricular ejection fraction (LVEF) >= 40%, however, subjects with a LVEF in
the range of 40-49% should have cardiology clearance prior to intervention

- MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must
demonstrate an unmethylated or hypomethylated MGMT promoter status

Exclusion Criteria:

- Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery
disease or arrhythmia, which has required or requires ongoing treatment

- Patients with active pulmonary infection and/or pulse oximetry < 90% and a corrected
diffusion capacity of the lung for carbon monoxide (DLCO) < 70% of predicted

- Active systemic infection

- Patients who are human immunodeficiency virus (HIV) positive

- Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be
obtained from women of childbearing potential; fertile men and women should use
effective contraception

- Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC)
or prior nitrosourea

- Diabetes mellitus

- Bleeding disorder

- Methylated or hypermethylated MGMT promoter status within tumor tissue

- Medical or psychiatric condition which in the opinion of the protocol chairman would
compromise the patient's ability to tolerate this protocol

- Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted
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