Malignant GliomaPhase 2NCT01351519
A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
A Phase 2 study testing Aminolevulinic Acid in people with Malignant Glioma and Glioma, run by MultiCare Health System Research Institute at 1 site in United States.
Trial summary
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma, Glioma, Glioblastoma
- What is being tested?
- Aminolevulinic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jan 2015
- Phase
- Phase 2
- 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
- Clinically documented primary brain tumor for which surgical resection is indicated.
- Age 18 years and older.
- ECOG Performance status less than or equal to 2.
- Laboratory values as follows:
- Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
- -Ability to provide informed consent or consent from a Legally Authorized Representative.
Who cannot join
- Receipt of an investigational agent within 30 days.
- Allergy to ALA or similar compounds.
- Personal or family history of porphyria.
- Uncontrolled intercurrent illness.
- Inability to comply with the protocol.
- Pregnancy, breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
MultiCare Health System Research Institute
Tacoma, Washington, 98405
About this study
Official title: A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
Read the detailed description
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
- Conditions
- Malignant Glioma, Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma
- Being tested
- Aminolevulinic Acid
- Keywords
- Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic AcidDrug
Also called ALA, 5-Aminolevulinic Acid, Levulan
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Aminolevulinic Acid (AL) | Experimental | Not described Receives: Drug: Aminolevulinic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression after initial surgery.
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Measured: Up to 2 years
Complete Resection
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
Measured: Day 2
Secondary outcomes (2)
Determine the number of subjects with adverse events due to ALA in this dosage and indication.
Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.
Measured: Through 45 days
Overall Survival
Determine the overall survival compared to historical controls.
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Limited staff available for enrollment and limited availability of drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Morris, MD, Principal investigator, MultiCare Health SystemRichard Shine, PharmD, BCPS, Study director, MultiCare Health System Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351519
- Sponsor's protocol ID
- ALA 11.07
- Status last verified
- Mar 2016
- First submitted
- 7 May 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
PubMed 16648043
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
- ClinicalTrials.gov ID
- NCT01351519
- Acronym / sponsor ID
- ALA 11.07
- Conditions
- Malignant Glioma, Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma
- Keywords
- Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited staff available for enrollment and limited availability of drug
- Enrolment
- 16 participants (actual)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 May 2011 (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.
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
Detailed description
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aminolevulinic Acid (AL) | Experimental | Drug: Aminolevulinic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically documented primary brain tumor for which surgical resection is indicated.
- Age 18 years and older.
- ECOG Performance status less than or equal to 2.
- Laboratory values as follows:
- Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
Key exclusion criteria (6 listed)
- Receipt of an investigational agent within 30 days.
- Allergy to ALA or similar compounds.
- Personal or family history of porphyria.
- Uncontrolled intercurrent illness.
- Inability to comply with the protocol.
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 |
|---|---|---|
| Aminolevulinic AcidAlso: ALA, 5-Aminolevulinic Acid, LevulanAminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery. | Drug | Aminolevulinic Acid (AL) |
Primary outcome
Time to disease progression after initial surgery.
Time frame: Up to 2 years
Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
Complete Resection
Time frame: Day 2
Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
2 secondary outcomes
Determine the number of subjects with adverse events due to ALA in this dosage and indication.
Time frame: Through 45 days
Overall Survival
Time frame: Up to three years
Results and safety
The study was stopped early (reason given: Limited staff available for enrollment and limited availability of drug). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Results publication: PubMed 16648043Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
Related trials for Malignant Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
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.
William Morris, MD principal investigator
MultiCare Health System
Richard Shine, PharmD, BCPS study director
MultiCare Health System Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolevulinic Acid in people with Malignant Glioma and Glioma, run by MultiCare Health System Research Institute 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 6 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: stopped early, as of the sponsor's last update on 17 Mar 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Limited staff available for enrollment and limited availability of drug). 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?
Time to disease progression after initial surgery. (time frame: Up to 2 years). 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?
On the ClinicalTrials.gov record for NCT01351519, which also lists 1 linked publication.
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 17 Mar 2016.