Status:
COMPLETED
Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
Lead Sponsor:
Diffusion Pharmaceuticals Inc
Conditions:
Glioblastoma
GBM
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 p...
Detailed Description
The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients was to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and ove...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01465347
Start Date
February 1 2012
End Date
February 1 2016
Last Update
July 14 2017
Active Locations (18)
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1
St. Joseph's Medical Center Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
2
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
3
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048