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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01465347
• Other study ID #: DP100-202
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 2, 2011
• Last updated: August 3, 2015
• Start date: February 2012
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Diffusion Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• GBM
• Glioblastoma
• Glioma
• High Grade Glioma

Intervention

Drug:
• Trans Sodium Crocetinate (TSC)
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UVA Health Sciences Center Emily Couric Clinical Cancer Center	Charlottesville	Virginia
United States	Northwestern University Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Florida McKnight Brain Institute	Gainesville	Florida
United States	Penn State University Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Health Science Center Memorial Hermann Medical Center	Houston	Texas
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky
United States	University of Arkansas Winthrop P. Rockefeller Cancer Institute	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Froedtert & Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	St. Joseph's Medical Center Barrow Neurology Clinics	Phoenix	Arizona
United States	The George Washington University Medical Center	Washington	District of Columbia
United States	Forsyth Regional Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Diffusion Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		24 months	No
Secondary	Quality of Life (QoL)	Evaluate QoL and daily functioning using EORTC QLQ-C30/BN20 and Karnofsky Performance Score(KPS)	Baseline, Week 6, Week 10, Week 18, Week 26, Week 52, Week 74 through Week 110	No