High Grade GliomaPhase 1NCT00826930
Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma
A Phase 1 study testing Trans Sodium Crocetinate (TSC) in people with High Grade Glioma, run by Diffusion Pharmaceuticals Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- Trans Sodium Crocetinate (TSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institute/Johns Hopkins Hospital
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read the 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.
- Conditions
- High Grade Glioma
- Being tested
- Trans Sodium Crocetinate (TSC)
- Keywords
- High Grade Glioma, Brain Tumor, Solid Tumor, Partial Debulking, Tumor Resection, Tumor Tissue Hypoxia, Radiation Sensitizer, Cancerous Tumor
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Sodium Crocetinate (TSC)Drug
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | 0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 2A | Experimental | 0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 3A | Experimental | 1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 4A | Experimental | 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 Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 1B | Experimental | 0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 2B | Experimental | 0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 3B | Experimental | 1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none Receives: Drug: Trans Sodium Crocetinate (TSC) |
| 4B | Experimental | 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 Receives: Drug: Trans Sodium Crocetinate (TSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in tumor tissue oxygen monitoring recordings
Measured: Daily while inpatient
Safety assessments (laboratory tests)
Measured: Daily while inpatient, 7-14 Day Follow-up
Secondary outcomes (2)
Pharmacokinetic assessments
Measured: Day 1, Day 2
Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX)
Measured: Daily while inpatient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Sponsor business decision, not based on safety or efficacy data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diffusion Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826930
- Sponsor's protocol ID
- DP100-201
- Status last verified
- Aug 2010
- First submitted
- 21 Jan 2009
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00826930
- Acronym / sponsor ID
- DP100-201
- Conditions
- High Grade Glioma
- Keywords
- High Grade Glioma, Brain Tumor, Solid Tumor, Partial Debulking, Tumor Resection, Tumor Tissue Hypoxia, Radiation Sensitizer, Cancerous Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision, not based on safety or efficacy data.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Diffusion Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Drug: Trans Sodium Crocetinate (TSC)0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none |
| 2A | Experimental | Drug: Trans Sodium Crocetinate (TSC)0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none |
| 3A | Experimental | Drug: Trans Sodium Crocetinate (TSC)1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none |
| 4A | Experimental | Drug: Trans Sodium Crocetinate (TSC)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 |
| 1B | Experimental | Drug: Trans Sodium Crocetinate (TSC)0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none |
| 2B | Experimental | Drug: Trans Sodium Crocetinate (TSC)0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none |
| 3B | Experimental | Drug: Trans Sodium Crocetinate (TSC)1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none |
| 4B | Experimental | Drug: Trans Sodium Crocetinate (TSC)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans Sodium Crocetinate (TSC)Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes. | Drug | 1A, 1B, 2A, 2B, 3A, 3B, 4A, 4B |
Primary outcome
Change from baseline in tumor tissue oxygen monitoring recordings
Time frame: Daily while inpatient
Safety assessments (laboratory tests)
Time frame: Daily while inpatient, 7-14 Day Follow-up
2 secondary outcomes
Pharmacokinetic assessments
Time frame: Day 1, Day 2
Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX)
Time frame: Daily while inpatient
Results and safety
The study was stopped early (reason given: Sponsor business decision, not based on safety or efficacy data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trans Sodium Crocetinate (TSC) in people with High Grade Glioma, run by Diffusion Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision, not based on safety or efficacy data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in tumor tissue oxygen monitoring recordings (time frame: Daily while inpatient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2010.