Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma

August 11, 2010 updated by: Diffusion Pharmaceuticals Inc

Open-label Study to Determine the Effect of Trans Sodium Crocetinate (TSC) on Intra-tumoral Oxygen Concentration, Tolerability, and Pharmacokinetics of TSC in Post-operative Patients With High Grade Glioma (HGG)

The purpose of this study is to evaluate the impact of Trans Sodium Crocetinate (TSC) on oxygen levels in brain tumor tissue in patients with high grade glioma. The proposed clinical indication for TSC is a radiation sensitizer for the treatment of cancerous tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this open-label, one-site study, up to 48 patients with high grade glioma (HGG) who are undergoing biopsy or partial debulking of the tumor as part of standard of care will have an oxygen monitoring probe placed in residual tumor tissue. Oxygen levels in the tumor tissue will be measured prior to and after administering a single bolus injection of TSC. Safety assessments will occur throughout the trial, including at a 7 to 14 day follow-up visit. Pharmacokinetic assessments will be performed prior to and during the first 24 hours after TSC dosing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medical Institute/Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years old.
  • Prior histological diagnosis of high grade glioma (HGG) with prior initial treatment and radiation therapy for HGG; recurrence of HGG suspected, and care plan includes surgical procedure.
  • Undergoing surgical procedure for clinical reasons, and gross surgical resection not expected.
  • Neurosurgeon is planning stereotactic biopsy or tumor debulking for clinical reasons; frozen tissue confirmation of malignancy during this operative procedure is necessary.
  • Neurosurgeon evaluates that placement of oxygen monitoring probe after biopsy or debulking can be done safely without complications.
  • Contrast enhancing disease on MRI within 21 days prior to enrollment.
  • Karnofsky Performance Score ≥ 60 at Screening.
  • Recovered from toxicity of prior antineoplastic therapy, and off cytotoxic chemotherapy for 7 days prior to Screening.
  • Recovered from prior radiotherapy and had at least 21 days elapse since completion of radiotherapy prior to Screening.
  • Recovered from prior surgery for their brain tumor in investigator's clinical judgment.
  • If female, negative serum or urine pregnancy test at Screening.
  • Within 2 weeks of starting study, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, serum bilirubin ≤ 1.5mg/dL, blood urea nitrogen within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm, and prothrombin time and partial thromboplastin time within institutional norm or below.
  • Patient or patient's medical power of attorney provided written consent to participate in the study.
  • Mini Mental Status Exam score ≥ 15.

Exclusion Criteria:

  • Pregnant or lactating.
  • Receiving concurrent cytotoxic chemotherapy for their tumor within 7 days prior to Screening, or decision is made at the time of surgery to treat with other modality of treatment (e.g., gliadel wafers).
  • Serious concurrent infection or medical illness which would jeopardize the ability of the patient to safely participate.
  • Behavioral, cognitive, or psychiatric disease or personal situation that might interfere with optimal participation.
  • Cannot undergo an MRI.
  • Received an investigational drug not approved for human use by the FDA within 30 days of enrollment.
  • Previously received TSC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1A
0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 2A
0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 3A
1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 4A
Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - phenytoin only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 1B
0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 2B
0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 3B
1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Experimental: 4B
Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - any except phenytoin-only or none
Drug: Trans Sodium Crocetinate (TSC)
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in tumor tissue oxygen monitoring recordings
Time Frame: Daily while inpatient
Daily while inpatient
Safety assessments (laboratory tests)
Time Frame: Daily while inpatient, 7-14 Day Follow-up
Daily while inpatient, 7-14 Day Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetic assessments
Time Frame: Day 1, Day 2
Day 1, Day 2
Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX)
Time Frame: Daily while inpatient
Daily while inpatient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diffusion Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DP100-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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