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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, GBM, Glioma, High Grade Glioma

Thank you

Trial Information

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


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.


Inclusion 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

24 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

DP100-202

NCT ID:

NCT01465347

Start Date:

February 2012

Completion Date:

September 2016

Related Keywords:

  • Glioblastoma
  • GBM
  • Glioma
  • High Grade Glioma
  • Primary brain tumor
  • Glioblastoma
  • Glioma
  • GBM
  • Radiation therapy
  • Glioblastoma
  • Glioma

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rush University Medical CenterChicago, Illinois  60612-3824
Cedars-Sinai Medical CenterLos Angeles, California  90048
North Shore University HospitalManhasset, New York  11030
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Baylor University Medical CenterDallas, Texas  75246
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Forsyth Regional Cancer CenterWinston-Salem, North Carolina  27103
University of Kentucky Markey Cancer CenterLexington, Kentucky  40536
Northwestern University Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611-2941
St. Joseph's Medical Center Barrow Neurology ClinicsPhoenix, Arizona  85013
The George Washington University Medical CenterWashington, District of Columbia  20037
UVA Health Sciences Center Emily Couric Clinical Cancer CenterCharlottesville, Virginia  22908
University of Arkansas Winthrop P. Rockefeller Cancer InstituteLittle Rock, Arkansas  72205
University of Florida McKnight Brain InstituteGainesville, Florida  32611
Penn State University Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
University of Texas Health Science Center Memorial Hermann Medical CenterHouston, Texas  77030
Froedtert & Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226