Clinical trial NCT01445691: More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
Official title: A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: 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
Keywords: 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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: NX PharmaGen
name: National Cancer Institute (NCI)
First posted: 2011-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Radicality of Brain Tumor Resection
timeFrame: Within the first 48 hours after surgery
Secondary outcomes:
measure: Progression-free survival every 3 months after surgery
timeFrame: Every 3 months until tumor progression on MRI
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Costas Hadjipanayis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: