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Trial record 8 of 809 for:    ALA

5-ALA in Recurrent Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by St. Joseph's Hospital and Medical Center, Phoenix
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT02119338
First received: April 11, 2014
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Recurrent Glioma
Drug: 5-ala

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Barrow ALA Trial for Recurrent Gliomas

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Presence of fluorescence in tumor tissue compared to tissue with treatment effect. [ Time Frame: day of surgery-1 day ] [ Designated as safety issue: No ]
    Correlation of fluorescence with pathological findings


Secondary Outcome Measures:
  • Extent of resection [ Time Frame: time within 48 hours post operative ] [ Designated as safety issue: No ]
    A postoperative MRI with contrast will be acquired within 48 hours of surgery. Volumetric analysis of contract T1-weighted images (for low grade gliomas) will be compared to the preoperative sequences to calculate the volume of residual disease. Slice-by-slice assessment of pre- and postoperative tumor volume will be quantified by sequentially measuring the area of tumor on each slice and then integrating the combined measurements. This methodology has been previously reported (Sanai et al., Journal of Neurosurgery, 2010; Sanai et al, The New England Journal of Medicine, 2008)

  • Progression-free survival rate at 6 months [ Time Frame: time from date of surgery to 6 months post surgery ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: time from date of surgery to date of death from any cause, assessed up to 100 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-ala preoperatively
A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.
Drug: 5-ala
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.
Other Names:
  • 5-aminolevulinic acid
  • Levulin(R)

Detailed Description:

The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.

Sub-goals:

  1. To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
  2. To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
  3. To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
  4. To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.

Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119338

Contacts
Contact: Nader Sanai, MD 602-406-3770 Nader.Sanai@bnaneuro.net
Contact: Norissa Honea, PhD, RN 602-406-6267 Norissa.Honea@dignityhealth.org

Locations
United States, Arizona
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Principal Investigator: Nader Sanai, MD Barrow Neurosurgical Associates
  More Information

No publications provided

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02119338     History of Changes
Other Study ID Numbers: 11BN092
Study First Received: April 11, 2014
Last Updated: October 22, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
5-ala
5-aminolevulinic acid
fluorescence-guided surgery
glioma
astrocytoma
glioblastoma
oligodendroglioma
recurrence of glioma

Additional relevant MeSH terms:
Aminolevulinic Acid
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015