Clinical Trial Details
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NCT01465347 : Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) With Concomitant Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM)
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Aged at least 18 years of age; male or female. A patient who is 70 years of age or
older may be considered for enrollment after review of patient clinical and
laboratory data by the Protocol Medical Monitor.

- Histologically confirmed diagnosis of GBM.

- Contrast enhancing disease on MRI within 21 days prior to Screening.

- Karnofsky score (KPS) of ? 60 at Screening.

- No prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a
biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.

- Within 2 weeks of Baseline visit, hematologic and renal functions as specified:
Absolute neutrophil count ? 1500/mm3, platelets ? 100,000/mm3, Hgb ? 9.0g/dL,
creatinine ? 1.7mg/dl, total bilirubin ? 1.5mg/dL, blood urea nitrogen (BUN) within 2
times the upper limit of normal, transaminases ? 4 times above the upper limits of
the institutional norm.

- Sexually active patients must use an acceptable method of contraception while
receiving doses of study medication.

- Females of childbearing potential must have a negative serum or urine pregnancy test
at Screening and have additional pregnancy tests during study.

Exclusion Criteria:

- Pt. who cannot undergo MRI.

- Pregnant or lactating.

- Serious concurrent infection or medical illness that would jeopardize the ability of
the patient to receive study treatment with reasonable safety.

- Pt. receiving concurrent chemotherapeutics or investigational agents within 30 days
of Baseline assessments, including gliadel wafers or gliasite application.
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