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More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Costas G. Hadjipanayis, Emory University
ClinicalTrials.gov Identifier:
NCT01445691
First received: September 30, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:

  • make sure that 5-ALA helps the doctor remove more of the tumor, and
  • make sure 5-ALA does not cause any side effects. If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

Condition Intervention Phase
Benign Neoplasms, Brain
Brain Cancer
Brain Neoplasms, Benign
Brain Neoplasms, Malignant
Brain Tumor, Primary
Brain Tumor, Recurrent
Brain Tumors
Intracranial Neoplasms
Neoplasms, Brain
Neoplasms, Intracranial
Primary Brain Neoplasms
Primary Malignant Brain Neoplasms
Primary Malignant Brain Tumors
Gliomas
Glioblastoma
Drug: 5-ALA (Gliolan)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: WCI1999-11: A Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Radicality of Brain Tumor Resection [ Time Frame: Within the first 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival every 3 months after surgery [ Time Frame: Every 3 months until tumor progression on MRI ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-ALA (Gliolan) Drug: 5-ALA (Gliolan)
20mg/kg administered once 3-5 hours prior to surgery
Other Names:
  • 5-ALA
  • Aminolevulinic acid

  Eligibility

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

Inclusion Criteria:

  • Patients must have a clinically documented primary brain tumor for which resection is clinically indicated. Individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study. Sixty (60) newly diagnosed and recurrent malignant gliomas will be enrolled in this study. The anticipated histology at resection should include: Anaplastic astrocytoma (10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme (10018337), or Gliosarcoma (10018340).
  • Prior therapy is not a consideration in protocol entry.
  • Age 18-80.
  • ECOG performance status <2 (Karnofsky >60%, see Appendix A).
  • Life expectancy is not a consideration for protocol entry.
  • Patients must have normal organ and marrow function as defined below:

Leukocytes >3,000/mL Absolute neutrophil count >1,500/mL Platelets >100,000/mL Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal Creatinine within normal institutional limits OR Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

  • The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior therapy is not an exclusion criterion.
  • Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI
  • Patients may not be receiving any experimental therapies.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides,fluoroquinolones, hypericin extracts) for 72 h.
  • Personal or family history of porphorias.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.Pregnant women are excluded from this study because aminolevulinic acid (ALA) is of unknown teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aminolevulinic acid (ALA), breastfeeding should be discontinued if the mother is treated with aminolevulinic acid (ALA)
  • Inclusion of Women and Minorities: Both men and women and members of all ethnic groups are eligible for this trial.
  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: NCT01445691

Contacts
Contact: Costas Hadjipanayis, MD, PhD 1-888-946-7447 chadjip@emory.edu

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stephanie Mcmillan       sjmcmil@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Costas Hadjipanayis, MD, PhD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Costas G. Hadjipanayis, MD, Emory University
ClinicalTrials.gov Identifier: NCT01445691     History of Changes
Other Study ID Numbers: IRB00051663, WCI1999-11
Study First Received: September 30, 2011
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Benign Neoplasms, Brain
Brain Cancer
Brain Neoplasms, Benign
Brain Neoplasms, Malignant
Brain Tumor, Primary
Brain Tumor, Recurrent
Brain Tumors
Intracranial Neoplasms
Neoplasms, Brain
Neoplasms, Intracranial
Primary Brain Neoplasms
Primary Malignant Brain Neoplasms
Primary Malignant Brain Tumors
Gliomas
Glioblastoma
Surgery
5-ALA
Aminolevulinic acid
Fluorescence

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

ClinicalTrials.gov processed this record on November 19, 2014