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Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (INTACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393000
Recruitment Status : Active, not recruiting
First Posted : January 8, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

Brief Summary:

Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.

Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.

The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Trans Sodium Crocetinate plus SOC Other: Standard of Care (SOC) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomized, controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : June 23, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Trans Sodium Crocetinate plus SOC
Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
Drug: Trans Sodium Crocetinate plus SOC
Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
Other Name: Trans Sodium Crocetinate (TSC) plus Standard of Care

Active Comparator: Standard of Care (SOC)
Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
Other: Standard of Care (SOC)
Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
Other Name: Standard of Care




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: All subjects will be followed for 24 months ]
    Overall survival will be calculated from randomization to the time of death from any cause


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: All subjects will be followed for 24 months ]
    Progression free survival will be calculated from the date of randomization to the date of first progression or death or last follow-up per Response Assessment in Neuro-Oncology (RANO) and modified RANO criteria

  2. Objective Response Rate (ORR) [ Time Frame: All subjects will be followed for 24 months ]
    Durable objective response rate (Complete Response [CR], Partial Response [PR]) will be estimated via radiological assessment per Response Assessment in Neuro-Oncology (RANO) and modified RANO criteria

  3. Karnofsky Performance Scale (KPS) [ Time Frame: All subjects will be followed for 24 months ]
    Functional status will be assessed by the investigators using the Karnofsky Performance Scale (KPS): total KPS scores range from 100 (normal), 90 (minor signs of disease), 80 (some sign or symptoms), 70 (unable to carry on normal activity), 60 (requires occasional assistance), 50 (requires considerable assistance), 40 (disabled), 30 (severely disabled), 29 (very sick), 10 (moribund) to 0 (dead); total KPS score will be used to assess eligibility at baseline (KPS > 60) and to assess subjects performance through the trial relative to baseline

  4. Quality of Life (EQ-5D-5L) [ Time Frame: All subjects will be followed for 24 months ]
    Quality of life will be assessed using the EQ-5D-5L visual analog scale: The EQ-5D-5L will be used by the subject to assess their view of their quality of life; This scale is numbered from 0 to 100 with 100 meaning the best health the subject can imagine to 0 meaning the worst health the subject can imagine; the subject will complete this scale at baseline and at the end of radiation treatment, again prior to and at the end of post-radiation treatment

  5. Corticosteroid Use [ Time Frame: All subjects will be followed for 24 months ]
    Corticosteroid medication use will be assessed throughout the trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects who are at least 18 to 70 years of age
  2. Have histologically confirmed GBM
  3. The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
  4. Measurable (>10mm x 10mm) contrast enhancing disease.
  5. Limited disturbance of tumor during biopsy.
  6. Surgical and pathology reports that document surgery was limited to biopsy and histologic confirmation.
  7. Life expectancy of at least 3 months.
  8. Subjects must have a Karnofsky score (KPS) of ≥ 60 at Screening.
  9. Glucocorticoid therapy allowed.
  10. Tumor Treatment Field (TT Fields) therapy allowed.
  11. If female, the subject must have a negative serum or urine pregnancy test at Screening unless meeting non-productive potential criteria.
  12. Subjects must have 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.
  13. The subject or subject's medical power of attorney has provided written consent to participate in this study.

Exclusion Criteria:

  1. Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
  2. Subjects must not have had prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy.
  3. Subject who is pregnant or lactating.
  4. Subject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety.
  5. Subject who cannot undergo MRI.
  6. Subject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.
  7. Subjects with other uncontrolled medical conditions, e.g. myocardial infarction, cerebrovascular accident, diabetes or hypertension.
  8. Subjects diagnosed with another malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix.
  9. CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393000


Locations
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United States, California
University of California
Irvine, California, United States, 92868
Scott Peak, M.D.
Redwood City, California, United States, 94063
John Wayne Cancer Institute @ Providence Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Georgia
Piedmont Cancer
Atlanta, Georgia, United States, 30318
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
UNM Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, South Carolina
Scott Lindhorst, M.D.
Charleston, South Carolina, United States, 29425
United States, Texas
Neuro Oncology Associates
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Diffusion Pharmaceuticals Inc
Investigators
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Study Director: Harry N Cook, RPH/MBA Diffusion Pharmaceuticals Inc

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Responsible Party: Diffusion Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03393000     History of Changes
Other Study ID Numbers: 100-206
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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