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A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain


Phase 2
18 Years
72 Years
Open (Enrolling)
Both
Glioma

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Trial Information

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain


The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of
fluorescent porphyrins in malignant gliomas will be used under investigation for
identification and resection of high grade gliomas. Surgery will be done using a modified
neurosurgical microscope, with a fluorescent kit that enables switching from the
conventional white light to a violet-blue excitation light for visualization during tumor
resection. If deemed safe by the neurosurgeon, any area of the resection bed determined to
be fluorescence-positive for tumor will be removed with appropriate designation of tissue
for histopathological evaluation. After this resection, additional fluorescence images will
be obtained and the process repeated until the image is negative for tumor. At all times,
the decision to resect will be limited by clinical judgment of safety.

The desire is that a more complete resection will occur due to the surgeon's ability to
better visualize and distinguish between tumor and normal tissue, and thus be able to remove
as much, or most of, the tumorous tissue, resulting in a better outcome for the patient, or
for future patients.


Inclusion Criteria:



1. Presumptive diagnosis of high grade glioma based on imaging studies, or will have
recurrent high-grade gliomas that have previously undergone diagnosis (astrocytoma,
oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma
multiforme). Both of these groups will be undergoing craniotomy for tumor resection.

2. Patient age 18 to 72 years.

3. Karnofsky performance of 60% or greater

4. Patients must have normal organ and marrow function as defined below:

Leukocytes >3,000/μL Absolute neutrophil count >1,500/μL Platelets >100,000/μL 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.

5. The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown.
Therefore, 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.

6. Patient must have the ability to understand and the willingness to sign a written
informed consent document or have a parent or guardian with the ability to understand
and the willingness to sign the written informed consent.

Exclusion Criteria:

1. Subjects with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to aminolevulinic acid (ALA).

2. Subjects with a history or family history of Porphyrias

3. Subjects with 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.

4. Pregnancy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells

Outcome Description:

To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells from normal cells leading to an increase in the amount of tumor removal during neurosurgical resection of malignant glioma.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Mitchel S Berger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Department of Neurosurgery

Authority:

United States: Food and Drug Administration

Study ID:

10101

NCT ID:

NCT01116661

Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Glioma
  • glioma
  • malignant high grade glioma
  • Brain Neoplasms
  • Neoplasms
  • Glioma

Name

Location

UCSF Department of NeurosurgerySan Francisco, California  94143