Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma

Completed · Phase 1/Phase 2

Conditions studied: Glioblastoma, GBM, Glioma

In brief

This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.

Key facts

Study ID

NCT01465347

Run by

Diffusion Pharmaceuticals Inc

People needed

59

Starts

2012-02-01

Expected to finish

2016-02-01

Last updated by the study team

2017-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient 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.
• Patient receiving concurrent chemotherapeutics or investigational agents within 30 days of baseline assessments, including gliadel wafers or gliasite application.

Where it is running

• St. Joseph's Medical Center Barrow Neurology Clinics — Phoenix, Arizona, United States
• University of Arkansas Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• The George Washington University Medical Center — Washington D.C., District of Columbia, United States
• University of Florida McKnight Brain Institute — Gainesville, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• North Shore University Hospital — Manhasset, New York, United States
• Forsyth Regional Cancer Center — Winston-Salem, North Carolina, United States
• Penn State University Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas Health Science Center Memorial Hermann Medical Center — Houston, Texas, United States
• UVA Health Sciences Center Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States
• Froedtert & Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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