Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) With Concomitant Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM)



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2012
End Date:September 2016

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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

This open-label study will evaluate 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 patients will receive TSC in the study. The objective of the
study is to evaluate the effect of TSC on survival and tumor response in patients with GBM
while establishing an acceptable patient risk profile.

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.
We found this trial at
18
sites
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Washington, District of Columbia
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Winston-Salem, North Carolina 27103
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