Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Condition: Glioblastoma
MeSH terms: Glioblastoma
Intervention: Trans Sodium Crocetinate plus SOC; Standard of Care (SOC)
Intervention description: Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide; Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
Intervention MeSH terms: Vitamin A; Trans-sodium crocetinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, randomized, controlled
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects who are at least 18 to 70 years of age

          2. Have histologically confirmed GBM

          3. The only surgical consideration is biopsy. Subjects who had gross total resection,
             partial resection and/or debulking are excluded.

          4. Measurable (>10mm x 10mm) contrast enhancing disease.

          5. Limited disturbance of tumor during biopsy.

          6. Surgical and pathology reports that document surgery was limited to biopsy and
             histologic confirmation.

          7. Life expectancy of at least 3 months.

          8. Subjects must have a Karnofsky score (KPS) of ≥ 60 at Screening.

          9. Glucocorticoid therapy allowed.

         10. Tumor Treatment Field (TT Fields) therapy allowed.

         11. If female, the subject must have a negative serum or urine pregnancy test at Screening
             unless meeting non-productive potential criteria.

         12. 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.

         13. The subject or subject's medical power of attorney has provided written consent to
             participate in this study.

        Exclusion Criteria:

          1. Subjects who had gross total tumor resection, partial resection, and/or debulking
             surgery.

          2. Subjects must not have had prior RT, chemotherapy (including Gliadel wafer),
             immunotherapy or therapy with a biologic agent, or hormonal therapy.

          3. Subject who is pregnant or lactating.

          4. Subject with a serious concurrent infection or medical illness that would jeopardize
             the ability of the subject to receive study treatment with reasonable safety.

          5. Subject who cannot undergo MRI.

          6. Subject receiving concurrent chemotherapeutics or investigational agents within 30
             days of study entry, including gliadel wafers or gliasite application.

          7. Subjects with other uncontrolled medical conditions, e.g. myocardial infarction,
             cerebrovascular accident, diabetes or hypertension.

          8. 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.

          9. CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea,
             vomiting).