5-ALA in Recurrent Glioma

NCT02119338 | Unknown

• 1 other identifier: 11BN092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.

Conditions

Glioma

Keywords

5-ala; 5-aminolevulinic acid; fluorescence-guided surgery; glioma; astrocytoma; glioblastoma; oligodendroglioma; recurrence of glioma

Outcome Measures

Primary Outcomes (1)

• Presence of fluorescence in tumor tissue compared to tissue with treatment effect.

  Correlation of fluorescence with pathological findings

  day of surgery-1 day

Secondary Outcomes (3)

• Extent of resection

  time within 48 hours post operative

• Progression-free survival rate at 6 months

  time from date of surgery to 6 months post surgery

• Overall survival

  time from date of surgery to date of death from any cause, assessed up to 100 months

Study Arms (1)

5-ala preoperatively

EXPERIMENTAL

A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.

Drug: 5-ala

Interventions

5-ala DRUG

dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.

Also known as: 5-aminolevulinic acid, Levulin(R)

5-ala preoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presumed recurrent glioma
• Age \> 18 years
• Normal bone marrow function (WBC \> 3000, Platelets \> 100,000)

You may not qualify if:

• Pregnancy
• History of photosensitivity, porphyria, or exfoliative dermatitis
• Hepatic dysfunction in the last 12 months \[defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin \> 2.5 x normal\]
• Serum creatinine \> 180 µmol/L
• Estimated Glomerular Filtration Rate (eGFR)\< 60 ml/min/1.73m2
• Inability to undergo MRI with contrast

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Astrocytoma; Glioblastoma; Oligodendroglioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Nader Sanai, MD

  Barrow Neurosurgical Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nader Sanai, MD

CONTACT

602-406-3770; Nader.Sanai@bnaneuro.net

Norissa Honea, PhD, RN

CONTACT

602-406-6267; Norissa.Honea@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 21, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

US (1)