Brain TumorsPhase 1NCT00671710
Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
A Phase 1 study testing Aminolevulinic Acid in people with Brain Tumors, run by Advocate Hospital System at 1 site in United States.
Trial summary
Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Aminolevulinic Acid
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients must have clinically documented primary brain tumor for which resection is clinically indicated. Anticipated histology at resection should include:anaplastic astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant, glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma, medulloblastoma, mixed astrocytoma-ependymoma
- prior therapy is not a consideration in protocol entry
- age unrestricted
- ECOG performance status<2(Karnofsky>60%,)
- life expectancy is not a consideration for protocol entry
- patients must have normal organ and marrow function as defined below:
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- 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
- women of child-bearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation.
- 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
- 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 adic (ALA)
- personal or family history of porphyrias
- 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
- pregnant women are excluded, breastfeeding should be discontinued if mother is treated with aminolevulinic acid.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.
- Conditions
- Brain Tumors
- Being tested
- Aminolevulinic Acid
- Keywords
- malignant glial brain tumors
- Medical subject headings
- 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
Escalating doses (10mg/kg, 20mg/kg, 30mg/kg) of Aminolevulinic Acid administered orally 3 hours prior to surgery to enhance visualization of malignant brain tumor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration.
Measured: 108 weeks
Secondary outcomes (1)
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA. Kaplan-Meier plots of survival and TTP will be generated for all study subjects and for patients at the 30 mg/kg dose level alone.
Measured: 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advocate Hospital System
- Sponsor type
- University, hospital or other
- Investigators
- John Ruge, M.D., Principal investigator, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671710
- Sponsor's protocol ID
- 4079
- Status last verified
- Jun 2010
- First submitted
- 30 Apr 2008
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
- ClinicalTrials.gov ID
- NCT00671710
- Acronym / sponsor ID
- 4079
- Conditions
- Brain Tumors
- Keywords
- malignant glial brain tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Advocate Hospital SystemUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 May 2008 (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.
Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- patients must have clinically documented primary brain tumor for which resection is clinically indicated. Anticipated histology at resection should include:anaplastic astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant, glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma, medulloblastoma, mixed astrocytoma-ependymoma
- prior therapy is not a consideration in protocol entry
- age unrestricted
- ECOG performance status<2(Karnofsky>60%,)
- life expectancy is not a consideration for protocol entry
Key exclusion criteria (5 listed)
- 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 adic (ALA)
- personal or family history of porphyrias
- 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
- pregnant women are excluded, breastfeeding should be discontinued if mother is treated with aminolevulinic acid.
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: ALAEscalating doses (10mg/kg, 20mg/kg, 30mg/kg) of Aminolevulinic Acid administered orally 3 hours prior to surgery to enhance visualization of malignant brain tumor. | Drug | – |
Primary outcome
Establish safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration.
Time frame: 108 weeks
1 secondary outcome
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA. Kaplan-Meier plots of survival and TTP will be generated for all study subjects and for patients at the 30 mg/kg dose level alone.
Time frame: 108 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
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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.
John Ruge, M.D. principal investigator
Advocate Lutheran General Hospital
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 Aminolevulinic Acid in people with Brain Tumors, run by Advocate Hospital 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 14 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jan 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration. (time frame: 108 weeks). 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 14 Jan 2011.