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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diffusion Pharmaceuticals Inc; Diffusion Pharmaceuticals LLC
• Treatments: Temozolomide; Trans-sodium crocetinate; Vitamin A

Criteria

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:

• 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.