Status:
TERMINATED
Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Lead Sponsor:
Diffusion Pharmaceuticals Inc
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Detailed Description
During the radiation treatment period subjects will receive: 1. Focal radiation delivered as 60 Gray/30 fractions scheduled at 2 Gray/day for 5 days each week (Monday through Friday) for 6 weeks. 2. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03393000
Start Date
January 16 2018
End Date
November 6 2020
Last Update
July 22 2021
Active Locations (13)
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1
University of California
Irvine, California, United States, 92868
2
Scott Peak, M.D.
Redwood City, California, United States, 94063
3
John Wayne Cancer Institute @ Providence Saint John's Health Center
Santa Monica, California, United States, 90404
4
Piedmont Cancer
Atlanta, Georgia, United States, 30318