A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

Glioblastoma Clinical Trial

Official title:

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01351519
• Other study ID #: ALA 11.07
• Status: Terminated
• Phase: Phase 2
• First received: May 7, 2011
• Last updated: March 15, 2016
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: MultiCare Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

Description:

This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically documented primary brain tumor for which surgical resection is indicated.

• Age 18 years and older.

• ECOG Performance status less than or equal to 2.

• Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria:

• Receipt of an investigational agent within 30 days.

• Allergy to ALA or similar compounds.

• Personal or family history of porphyria.

• Uncontrolled intercurrent illness.

• Inability to comply with the protocol.

• Pregnancy, breastfeeding.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Malignant Glioma

Intervention

Drug:
• Aminolevulinic Acid
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.

Locations

Country	Name	City	State
United States	MultiCare Health System Research Institute	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MultiCare Health System Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression after initial surgery.	Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.	Up to 2 years	No
Primary	Complete Resection	Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls	Day 2	No
Secondary	Determine the number of subjects with adverse events due to ALA in this dosage and indication.	Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.	Through 45 days	Yes
Secondary	Overall Survival	Determine the overall survival compared to historical controls.	Up to three years	No