Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects

Stopped early · Phase 3

Conditions studied: Glioblastoma

In brief

Open-label, randomized, controlled, phase 3 safety and efficacy registration trial. Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care. The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.

Key facts

Study ID

NCT03393000

Run by

Diffusion Pharmaceuticals Inc

People needed

19

Starts

2018-01-16

Expected to finish

2020-11-06

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects who are at least 18 to 70 years of age
• Have histologically confirmed GBM
• The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
• Measurable (>10mm x 10mm) contrast enhancing disease.
• Limited disturbance of tumor during biopsy.
• Surgical and pathology reports that document surgery was limited to biopsy and histologic confirmation.
• Life expectancy of at least 3 months.
• Subjects must have a Karnofsky score (KPS) of ≥ 60 at Screening.
• Glucocorticoid therapy allowed.
• Tumor Treatment Field (TT Fields) therapy allowed.
• If female, the subject must have a negative serum or urine pregnancy test at Screening unless meeting non-productive potential criteria.
• Subjects must have 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.
• The subject or subject's medical power of attorney has provided written consent to participate in this study.

You may not qualify if…

• Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
• Subjects must not have had prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy.
• Subject who is pregnant or lactating.
• Subject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety.
• Subject who cannot undergo MRI.
• Subject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.
• Subjects with other uncontrolled medical conditions, e.g. myocardial infarction, cerebrovascular accident, diabetes or hypertension.
• Subjects diagnosed with another malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix.
• CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting).

Where it is running

• University of California — Irvine, California, United States
• Scott Peak, M.D. — Redwood City, California, United States
• John Wayne Cancer Institute @ Providence Saint John's Health Center — Santa Monica, California, United States
• Piedmont Cancer — Atlanta, Georgia, United States
• John B. Amos Cancer Center — Columbus, Georgia, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• UNM Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• North Shore University Hospital — Manhasset, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Scott Lindhorst, M.D. — Charleston, South Carolina, United States
• Neuro Oncology Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.