Trial Outcomes & Findings for Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain (NCT NCT01116661)

NCT ID: NCT01116661

Last Updated: 2019-05-29

Results Overview

Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 199 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	Single Dose ALA for Newly Diagnosed and Recurrent HGG 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery for both newly diagnosed and recurrent High grade gliomas
Overall Study STARTED	199
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

Baseline characteristics by cohort

Measure	5 - Aminolevuline Acid in Patients With HGG n=197 Participants 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	160 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	162 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants
Region of Enrollment United States	197 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All patient who received 5-Aminolevuline Acid prior to surgical resection

Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues

Outcome measures

Measure	5- Aminolevuline Acid Given to HGG Participants n=197 Participants 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
The Percentage of Biopsies Taken From the Most Fluorescent Tissues That Have Tumorous Content.	90.9 percentage of biopsies Interval 9.9 to 100.0

SECONDARY outcome

Timeframe: 14 days

Population: Patients who received study drug

Number of Participants with Adverse Events, as defined by grade 3 to 5 AEs and SAEs related to study drug. .

Outcome measures

Measure	5- Aminolevuline Acid Given to HGG Participants n=197 Participants 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
Number of Participants With Adverse Events	14 Participants

Adverse Events

5- Aminolevuline Acid Given to HGG Participants

Serious events: 12 serious events

Other events: 25 other events

Deaths: 59 deaths

Serious adverse events

Measure	5- Aminolevuline Acid Given to HGG Participants n=199 participants at risk 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
Cardiac disorders Hypotension	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Nervous system disorders Intracranial hemorrhage	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Infections and infestations Infection - with Grade 3 or 4 nuetrophils	0.50% 1/199 • Number of events 2 • From time of ALA dosing up to 14 days post- operative
Infections and infestations Infection - other	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders Hyponatremia	1.0% 2/199 • Number of events 2 • From time of ALA dosing up to 14 days post- operative
Nervous system disorders Mental status	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Nervous system disorders Seizure	2.0% 4/199 • Number of events 4 • From time of ALA dosing up to 14 days post- operative
Vascular disorders thrombosis/embolism	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Vascular disorders Vascular - other	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative

Other adverse events

Measure	5- Aminolevuline Acid Given to HGG Participants n=199 participants at risk 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
Blood and lymphatic system disorders Lymphopenia	1.5% 3/199 • Number of events 4 • From time of ALA dosing up to 14 days post- operative
Skin and subcutaneous tissue disorders Photosensitivity	2.5% 5/199 • Number of events 8 • From time of ALA dosing up to 14 days post- operative
Skin and subcutaneous tissue disorders Dermatology/skin	1.5% 3/199 • Number of events 3 • From time of ALA dosing up to 14 days post- operative
Skin and subcutaneous tissue disorders Dry Skin	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Skin and subcutaneous tissue disorders Flushing	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders ALT,SGPT increase	1.0% 2/199 • Number of events 2 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders Alkaline Phosphatase	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders AST,SGOT increase	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders Hyperbilirubinemia	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Blood and lymphatic system disorders Hemoglobin decrease	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Cardiac disorders Hypotension	1.0% 2/199 • Number of events 2 • From time of ALA dosing up to 14 days post- operative
Cardiac disorders hypertension	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
General disorders Fatigue	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Skin and subcutaneous tissue disorders Pain - skin	0.50% 1/199 • Number of events 1 • From time of ALA dosing up to 14 days post- operative
Metabolism and nutrition disorders metabolic/Laboratory - other	1.5% 3/199 • Number of events 3 • From time of ALA dosing up to 14 days post- operative

Additional Information

Mitch Berger, MD; Director of Neurosurgery

University of California San Francisco

Phone: 415-353-7500

Email: Mtich.Berger@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place