Benign Neoplasms, BrainPhase 2NCT01445691
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
A Phase 2 study testing 5-ALA (Gliolan) in people with Benign Neoplasms, Brain and Brain Cancer, run by Constantinos Hadjipanayis at 6 sites in United States.
Trial summary
The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Benign Neoplasms, Brain, Brain Cancer, Brain Neoplasms, Benign
- What is being tested?
- 5-ALA (Gliolan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a clinically documented primary brain tumor for which resection is clinically indicated. Individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study. The anticipated histology at resection should include: Anaplastic astrocytoma (10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme (10018337), or Gliosarcoma (10018340).
- Prior therapy is not a consideration in protocol entry.
- Age 18-80.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
- Life expectancy is not a consideration for protocol entry.
- Subjects must have normal organ and marrow function as defined below:
Show all 14Show fewer
- Leukocytes ≥ 3,000/mL
- Platelets ≥ 100,000/mL
- Total bilirubin below upper limit of normal
- Aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine below upper limit of normal OR
- Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
- The effects of aminolevulinic acid (ALA) on the developing human fetus are unknown. For this reason, 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A pregnancy test will be performed for all women of childbearing ability prior to surgery. Women who are pregnant will be excluded from the trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI.
- Subjects may not be receiving any experimental therapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides,fluoroquinolones, hypericin extracts) for 72 hours.
- 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 from this study because aminolevulinic acid (ALA) is of unknown teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aminolevulinic acid (ALA), breastfeeding should be discontinued if the mother is treated with aminolevulinic acid (ALA).
- Women who are pregnant will be excluded from the trial.
- Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
- Inclusion of women and minorities: both men and women and members of all ethnic groups are eligible for this trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Henry Ford Health System
Detroit, Michigan, 48202
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas
The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:
- Make sure that 5-ALA helps the doctor remove more of the tumor.
- Make sure 5-ALA does not cause any side effects.
If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.
- Conditions
- Benign Neoplasms, Brain, Brain Cancer, Brain Neoplasms, Benign, Brain Neoplasms, Malignant, Brain Tumor, Primary, Brain Tumor, Recurrent
- Being tested
- 5-ALA (Gliolan)
- Keywords
- Benign Neoplasms, Brain, Brain Cancer, Brain Neoplasms, Benign, Brain Neoplasms, Malignant, Brain Tumor, Primary, Brain Tumor, Recurrent, Brain Tumors, Intracranial Neoplasms, Neoplasms, Brain, Neoplasms, Intracranial, Primary Brain Neoplasms, Primary Malignant Brain Neoplasms, Primary Malignant Brain Tumors, Gliomas, Glioblastoma, Surgery, 5-ALA, Aminolevulinic acid, Fluorescence
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ALA (Gliolan)Drug
Also called 5-ALA, Aminolevulinic acid, Gliolan
20 mg/kg administered once 3-5 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA (Gliolan) | Experimental | Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue. Receives: Drug: 5-ALA (Gliolan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radicality of Brain Tumor Resection
Measured: Within the first 48 hours after surgery
Secondary outcomes (1)
Progression-free survival every 3 months after surgery
Measured: Every 3 months until tumor progression on MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startNov 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neoplasms, BrainStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Constantinos Hadjipanayis
- Sponsor type
- University, hospital or other
- Collaborators
- NX PharmaGen, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai
- Investigators
- Costas Hadjipanayis, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445691
- Sponsor's protocol ID
- GCO 15-2034
- Other IDs
- WCI1999-11, R01CA176659, R21CA186169, IRB00051663
- Status last verified
- May 2016
- First submitted
- 30 Sep 2011
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT01445691
- Acronym / sponsor ID
- GCO 15-2034
- Conditions
- Benign Neoplasms, Brain, Brain Cancer, Brain Neoplasms, Benign, Brain Neoplasms, Malignant, Brain Tumor, Primary, Brain Tumor, Recurrent
- Keywords
- Benign Neoplasms, Brain, Brain Cancer, Brain Neoplasms, Benign, Brain Neoplasms, Malignant, Brain Tumor, Primary, Brain Tumor, Recurrent, Brain Tumors, Intracranial Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Constantinos HadjipanayisUniversity, hospital or other
- Collaborators
- NX PharmaGen, National Cancer Institute (NCI)
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Oct 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.
The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:
- Make sure that 5-ALA helps the doctor remove more of the tumor.
- Make sure 5-ALA does not cause any side effects.
If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-ALA (Gliolan) | Experimental | Drug: 5-ALA (Gliolan)Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must have a clinically documented primary brain tumor for which resection is clinically indicated. Individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study. The anticipated histology at resection should include: Anaplastic astrocytoma (10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme (10018337), or Gliosarcoma (10018340).
- Prior therapy is not a consideration in protocol entry.
- Age 18-80.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
- Life expectancy is not a consideration for protocol entry.
Key exclusion criteria (8 listed)
- Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI.
- Subjects may not be receiving any experimental therapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides,fluoroquinolones, hypericin extracts) for 72 hours.
- 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 from this study because aminolevulinic acid (ALA) is of unknown teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aminolevulinic acid (ALA), breastfeeding should be discontinued if the mother is treated with aminolevulinic acid (ALA).
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-ALA (Gliolan)Also: 5-ALA, Aminolevulinic acid, Gliolan20 mg/kg administered once 3-5 hours prior to surgery | Drug | 5-ALA (Gliolan) |
Primary outcome
Radicality of Brain Tumor Resection
Time frame: Within the first 48 hours after surgery
1 secondary outcome
Progression-free survival every 3 months after surgery
Time frame: Every 3 months until tumor progression on MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
Costas Hadjipanayis, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
6 sites 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-ALA (Gliolan) in people with Benign Neoplasms, Brain and Brain Cancer, run by Constantinos Hadjipanayis at 6 sites 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 8 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: withdrawn, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Radicality of Brain Tumor Resection (time frame: Within the first 48 hours 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 17 May 2016.