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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01445691
Recruitment Status : Withdrawn
First Posted : October 4, 2011
Last Update Posted : May 17, 2016
Sponsor:
Collaborators:
NX PharmaGen
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE September 30, 2011
First Posted Date  ICMJE October 4, 2011
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2011)
Radicality of Brain Tumor Resection [ Time Frame: Within the first 48 hours after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2011)
Progression-free survival every 3 months after surgery [ Time Frame: Every 3 months until tumor progression on MRI ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
Official Title  ICMJE A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas
Brief Summary

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.
  • 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: 5-ALA (Gliolan)
20 mg/kg administered once 3-5 hours prior to surgery
Other Names:
  • 5-ALA
  • Aminolevulinic acid
  • Gliolan
Study Arms  ICMJE Experimental: 5-ALA (Gliolan)
Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.
Intervention: Drug: 5-ALA (Gliolan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2011)
60
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects 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. 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
  • Life expectancy is not a consideration for protocol entry.
  • Subjects must have normal organ and marrow function as defined below:

    • Leukocytes ≥ 3,000/mL
    • Platelets ≥ 100,000/mL
    • Total bilirubin below upper limit of normal
    • Aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT) ≤ 2.5 X institutional upper limit of normal
    • Creatinine below upper limit of normal 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. A pregnancy test will be performed for all women of childbearing ability prior to surgery. Women who are pregnant will be excluded from the trial.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI.
  • Subjects 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 hours.
  • Personal or family history of porphyrias.
  • 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).
  • Women who are pregnant will be excluded from the trial.
  • Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
  • Inclusion of women and minorities: both men and women and members of all ethnic groups are eligible for this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01445691
Other Study ID Numbers  ICMJE GCO 15-2034
WCI1999-11 ( Other Identifier: Other )
R01CA176659 ( U.S. NIH Grant/Contract )
R21CA186169 ( U.S. NIH Grant/Contract )
IRB00051663 ( Other Identifier: Emory University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Constantinos Hadjipanayis
Collaborators  ICMJE
  • NX PharmaGen
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Costas Hadjipanayis, MD, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP