GliomaNCT02119338
5-ALA in Recurrent Glioma
A study testing 5-ala in people with Glioma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- 5-ala
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2017
- Phase
- Interventional
- 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
- Presumed recurrent glioma
- Age > 18 years
- Normal bone marrow function (WBC > 3000, Platelets > 100,000)
Who cannot join
- Pregnancy
- History of photosensitivity, porphyria, or exfoliative dermatitis
- Hepatic dysfunction in the last 12 months [defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin > 2.5 x normal]
- Serum creatinine > 180 µmol/L
- Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73m2
- Inability to undergo MRI with contrast
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: Barrow ALA Trial for Recurrent Gliomas
The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.
Read the detailed description
The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.
Sub-goals:
- To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
- To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.
Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.
- Conditions
- Glioma
- Being tested
- 5-ala
- Keywords
- 5-ala, 5-aminolevulinic acid, fluorescence-guided surgery, glioma, astrocytoma, glioblastoma, oligodendroglioma, recurrence of glioma
- Medical subject headings
- Glioma, Astrocytoma, Glioblastoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-alaDrug
Also called 5-aminolevulinic acid, Levulin(R)
dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.
| Study group | Role | What they receive |
|---|---|---|
| 5-ala preoperatively | Experimental | A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery. Receives: Drug: 5-ala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
Correlation of fluorescence with pathological findings
Measured: day of surgery-1 day
Secondary outcomes (3)
Extent of resection
A postoperative MRI with contrast will be acquired within 48 hours of surgery. Volumetric analysis of contract T1-weighted images (for low grade gliomas) will be compared to the preoperative sequences to calculate the volume of residual disease. Slice-by-slice assessment of pre- and postoperative tumor volume will be quantified by sequentially measuring the area of tumor on each slice and then integrating the combined measurements. This methodology has been previously reported (Sanai et al., Journal of Neurosurgery, 2010; Sanai et al, The New England Journal of Medicine, 2008)
Measured: time within 48 hours post operative
Progression-free survival rate at 6 months
Measured: time from date of surgery to 6 months post surgery
Overall survival
Measured: time from date of surgery to date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nader Sanai, MD, Principal investigator, Barrow Neurosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119338
- Sponsor's protocol ID
- 11BN092
- Status last verified
- Jan 2017
- First submitted
- 11 Apr 2014
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrow ALA Trial for Recurrent Gliomas
- ClinicalTrials.gov ID
- NCT02119338
- Acronym / sponsor ID
- 11BN092
- Conditions
- Glioma
- Keywords
- 5-ala, 5-aminolevulinic acid, fluorescence-guided surgery, glioma, astrocytoma, glioblastoma, oligodendroglioma, recurrence of glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Apr 2014 (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 investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.
Detailed description
The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.
Sub-goals:
- To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
- To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.
Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-ala preoperatively | Experimental | Drug: 5-alaA dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presumed recurrent glioma
- Age > 18 years
- Normal bone marrow function (WBC > 3000, Platelets > 100,000)
Key exclusion criteria (6 listed)
- Pregnancy
- History of photosensitivity, porphyria, or exfoliative dermatitis
- Hepatic dysfunction in the last 12 months [defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin > 2.5 x normal]
- Serum creatinine > 180 µmol/L
- Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73m2
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 |
|---|---|---|
| 5-alaAlso: 5-aminolevulinic acid, Levulin(R)dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery. | Drug | 5-ala preoperatively |
Primary outcome
Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
Time frame: day of surgery-1 day
Correlation of fluorescence with pathological findings
3 secondary outcomes
Extent of resection
Time frame: time within 48 hours post operative
Progression-free survival rate at 6 months
Time frame: time from date of surgery to 6 months post surgery
Overall survival
Time frame: time from date of surgery to date of death from any cause, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Nader Sanai, MD principal investigator
Barrow Neurosurgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-ala in people with Glioma, run by St. Joseph's Hospital and Medical Center, Phoenix 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nader Sanai, MD (602-406-3770, Nader.Sanai@bnaneuro.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of fluorescence in tumor tissue compared to tissue with treatment effect. (time frame: day of surgery-1 day). 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 6 Jan 2017; AzTrials last refreshed its copy on 2 Nov 2026.