GliomaPhase 2ALANCT01403311
A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
A Phase 2 study testing 5-Aminolevuline Acid in people with Glioma, run by Legacy Health System at 1 site in United States.
Trial summary
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery. 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-Aminolevuline Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 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
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- Patients may have prior therapy
- 18 years of age
- Male or Female
- Life expectancy is not a consideration for protocol entry
- Patients must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
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- Confirmation of Glial Tumor
- Gross total resection is the aim of surgery
- Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- Tumor with perforating vessels
- Tumor involves critical fiber tracks
- Use of the microsurgical tool monopolar loop
- Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
- Performance Status of less than 60
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- Prior therapy is not an exclusion criterion
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA)
- Personal or family history of porphorias
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
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
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Read the detailed description
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
- Conditions
- Glioma
- Being tested
- 5-Aminolevuline Acid
- Keywords
- Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma, ALA
- Medical subject headings
- Glioma, Astrocytoma, Ependymoma, Glioblastoma, Gliosarcoma, Oligodendroglioma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevuline AcidDrug
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| ALA | Experimental | 5-Aminolevuline Acid (ALA) Receives: Drug: 5-Aminolevuline Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
Measured: participants will be followed while in the hospital and for 12 weeks after surgery
Secondary outcomes (1)
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
Measured: participants will be followed for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionMar 2015 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Jefferson W Chen, MD, Legacy Health System
- Investigators
- Jefferson Chen, MD, PhD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403311
- Sponsor's protocol ID
- 5-ALA-01
- Acronym
- ALA
- Status last verified
- Mar 2014
- First submitted
- 25 Jul 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. 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
- NCT01403311
- Acronym / sponsor ID
- ALA / 5-ALA-01
- Conditions
- Glioma
- Keywords
- Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 27 Jul 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.
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
Detailed description
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALA | Experimental | Drug: 5-Aminolevuline Acid5-Aminolevuline Acid (ALA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have clinically documented primary brain tumor for which resection is clinically indicated. The anticipated histology at resection should include: Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma, Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed astrocytoma-ependymoma
- Patients may have prior therapy
- 18 years of age
- Male or Female
- Life expectancy is not a consideration for protocol entry
Key exclusion criteria (11 listed)
- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis
- Tumor with perforating vessels
- Tumor involves critical fiber tracks
- Use of the microsurgical tool monopolar loop
- Subject has preexisting severe deficits concerning language or motor function not resolved with steroids
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-Aminolevuline Acid5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery | Drug | ALA |
Primary outcome
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
Time frame: participants will be followed while in the hospital and for 12 weeks after surgery
1 secondary outcome
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
Time frame: participants will be followed for 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Jefferson Chen, MD, PhD principal investigator
Legacy Health System
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 5-Aminolevuline Acid in people with Glioma, run by Legacy Health System 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 9 inclusion and 11 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 26 Mar 2014. 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?
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?
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively (time frame: participants will be followed while in the hospital and for 12 weeks after surgery). 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 26 Mar 2014.