Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) With Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Patients to Evaluate Safety and Efficacy
Description
Detailed Description
The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients are
to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease
progression, QoL, and overall survival in adults when TSC is added to the standard of care
regimen of radiation therapy and temozolomide. All patients will receive TSC in this study.
The primary objective of the Phase 1 portion of the study is to evaluate the safety (DLT
rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary
clinical endpoint is overall survival at 24 months and patients will be followed for up to 3
years.
Phase
Phase 1/2 - for trials that are a combination of phases 1 and 2.Inclusion and Exclusion 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.
- Pt. 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.
- Pt. receiving concurrent chemotherapeutics or investigational agents within 30 days of Baseline assessments, including gliadel wafers or gliasite application.
Sites
-
California
- Cedars-Sinai Medical Center, Los Angeles, California, 90048
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Arizona
- St. Joseph's Medical Center Barrow Neurology Clinics, Phoenix, Arizona, 85013
-
Texas
- Baylor University Medical Center, Dallas, Texas, 75246
- University of Texas Health Science Center Memorial Hermann Medical Center, Houston, Texas, 77030
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Arkansas
- University of Arkansas Winthrop P. Rockefeller Cancer Institute, Little Rock, Arkansas, 72205
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Wisconsin
- Froedtert & Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226
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Illinois
- Rush University Medical Center, Chicago, Illinois, 60612
- Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, 60611
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Kentucky
- University of Kentucky Markey Cancer Center, Lexington, Kentucky, 40536
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Georgia
- Emory University Winship Cancer Institute, Atlanta, Georgia, 30322
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