Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
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|ClinicalTrials.gov Identifier: NCT01502605|
Recruitment Status : Terminated (PI leaving institution)
First Posted : December 30, 2011
Last Update Posted : January 5, 2017
This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.
Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.
This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.
The purpose of this study is to:
- Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
- Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
- Make sure the 5-ALA identifies tumor and not normal brain
- Make sure 5-ALA does not cause any side effects
|Condition or disease||Intervention/treatment||Phase|
|Astrocytoma Glioma||Drug: 5-Aminolevulinic Acid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2016|
This arm will receive the investigational agent, 5-ALA.
Drug: 5-Aminolevulinic Acid
A one time, single-dose administration of ALA is planned 4 hours pre-operatively the day of surgery. ALA will be mixed in the minimum volume of sterile water or juice immediately before use and given as a single oral bolus. Once ALA has been administered, patients will be kept in subdued lighting away from sunlight.
- serious adverse event (SAE) Rate [ Time Frame: 2 weeks from dosing ]
It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing):
Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity
- Diagnostic Accuracy [ Time Frame: 72 hours post-operative ]The secondary objective of the study is to estimate sensitivity (true positive rate) and specificity (true negative rate); false positive rate and false negative rate; positive predict rate, and negative predict rate using a 5-ALA dose of 20 mg/kg to delineate tumor that may provide discrimination between normal and malignant tissue intra-operatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502605
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Alfredo Quinones, MD||Johns Hopkins School of Medicine|