Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
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
1 other identifier
interventional
59
1 country
18
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 patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2012
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
July 14, 2017
CompletedJuly 14, 2017
June 1, 2017
3.8 years
November 2, 2011
October 4, 2016
June 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Limiting Toxicities (DLTs)
Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)
During phase 1
Overall Survival
Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.
6, 12, 18, 24 months
Secondary Outcomes (2)
Progression-Free Survival (PFS)
6,12,18, 24 months
Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction
From Baseline to Week 110
Study Arms (1)
TSC 0.25 mg/kg for 9 or 18 doses
EXPERIMENTALThis was an open-label, sequential-cohort, dose-escalation study in two phases. Phase 1 was a safety run-in evaluating Trans Sodium Crocetinate (TSC) in 3 subjects who received 3 doses per week for 3 weeks (9 doses in total). Phase 2 engaged 56 subjects who received 3 doses per week for 6 weeks (18 doses in total). TSC was consistently dosed at 0.25mg/kg in both phases.
Interventions
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
St. Joseph's Medical Center Barrow Neurology Clinics
Phoenix, Arizona, 85013, United States
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
University of Florida McKnight Brain Institute
Gainesville, Florida, 32611, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Health Science Center Memorial Hermann Medical Center
Houston, Texas, 77030, United States
UVA Health Sciences Center Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22908, United States
Froedtert & Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PMID: 15758009RESULTGainer JL, Sheehan JP, Larner JM, Jones DR. Trans sodium crocetinate with temozolomide and radiation therapy for glioblastoma multiforme. J Neurosurg. 2017 Feb;126(2):460-466. doi: 10.3171/2016.3.JNS152693. Epub 2016 May 13.
PMID: 27177177DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Executive Officer
- Organization
- Diffusion Pharmaceuticals Inc
Study Officials
- STUDY CHAIR
David R. Jones, M.D.
Diffusion Pharmaceuticals Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 4, 2011
Study Start
February 1, 2012
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
July 14, 2017
Results First Posted
July 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share