Trial record 2 of 3 for:    Trans Sodium Crocetinate (TSC)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Diffusion Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01465347
First received: November 2, 2011
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Glioblastoma
GBM
Glioma
High Grade Glioma
Drug: Trans Sodium Crocetinate (TSC)
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Diffusion Pharmaceuticals LLC:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: Baseline, Week 6, Week 10, Week 18, Week 26, Week 52, Week 74 through Week 110 ] [ Designated as safety issue: No ]
    Evaluate QoL and daily functioning using EORTC QLQ-C30/BN20 and Karnofsky Performance Score(KPS)


Enrollment: 59
Study Start Date: February 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TSC 0.25 mg/kg for 9 or 18 doses Drug: Trans Sodium Crocetinate (TSC)
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465347

Locations
United States, Arizona
St. Joseph's Medical Center Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
United States, Arkansas
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida McKnight Brain Institute
Gainesville, Florida, United States, 32611
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas Health Science Center Memorial Hermann Medical Center
Houston, Texas, United States, 77030
United States, Virginia
UVA Health Sciences Center Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Froedtert & Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Diffusion Pharmaceuticals LLC
  More Information

No publications provided

Responsible Party: Diffusion Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01465347     History of Changes
Other Study ID Numbers: DP100-202
Study First Received: November 2, 2011
Last Updated: October 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Diffusion Pharmaceuticals LLC:
Primary brain tumor
Glioblastoma
Glioma
GBM
Radiation therapy

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Temozolomide
Vitamin A
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014