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tumors in the rear of his cerebrum and near ventricles. Two of these patients
were females, and two were males.
Two of the six patients with glioma receiving 18 F-FHBG PET scans were also
enrolled in another trial, receiving genetically engineered autologous CTLs
(described in Section 21.2.3). The first patient (CTL patient 1) was a 57-year-old
Caucasian man diagnosed with grade IV glioblastoma multiforme, 1 year prior
to the CTL infusions and the 18 F-FHBG PET scan. This patient had received 12
sessions of intracranial CTL infusions after resection of his recurrent tumor in
the right parietal occipital lobe of his brain, directly into the tumor resection
site. He received a single 18 F-FHBG tracer injection and had a single whole-body
PET scan 3 days after completion of the CTL infusions. At the time the first
patient was enrolled, the FDA only allowed a single 18 F-FHBG PET scan per
patient. The second patient (CTL patient 2) was a 41-year-old Caucasian woman
who had been diagnosed with glioblastoma in the right parieto-occipital lobe
of her brain 4.5 years prior to receiving CTL infusions. This patient had a recur-
rent tumor in the same area in November 2008. The patient had a 18 F-FHBG PET
scan once prior to CTL infusions and a second time 3 days after completion of
the 12 sessions of CTL infusions. CTL patients 1 and 2 met the inclusion and
exclusion criteria discussed next prior to enrollment in the cell therapy trial.
21.2.2.1  Inclusion Criteria for Study Enrollment
Histological verification of grade III or IV malignant glioma at origi-
nal diagnosis
Male or female subjects between 18 and 70 years, inclusive
Unifocal site of original disease in the cerebral cortex
Primary therapy completed and steroid independent no less than 4 weeks
If patient is taking adjunct cytotoxic chemotherapy, must be at least
2 weeks from finishing most recent course and recovered from all
acute side effects
Adequate renal function as evidenced by creatinine below 1.6.
Adequate bone marrow function as evidenced by white blood cells
(WBCs) 2,000/dL or higher (or Absolute Neutrophil Count [ANC]
> 1,000) and platelets 100,000/dL or higher unsupported by transfu-
sion or growth factor
Normal liver function as evidenced by bilirubin below 1.5 and SGOT
(aspartate aminotransferase) and SGPT (alanine aminotransferase)
more than twice upper limits of normal
Female patients of childbearing potential must not be pregnant as evi-
denced by a serum β-hCG (human chorionic gonadotropin) preg-
nancy test obtained within 7 days of enrollment
Participants having reproductive potential must agree to use effective
contraception during participation on this protocol
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