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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Glioma, Glioma, Glioblastoma, Glioblastoma Multiforme, Astrocytoma

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Trial Information

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


This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a
dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with
the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to
determine whether the tumor has been completely or partially resected. All subjects will be
followed for safety. All subjects will be followed closely by clinical examination and by
MRI to monitor for disease recurrence.


Inclusion Criteria:



- Clinically documented primary brain tumor for which surgical resection is indicated.

- Age 18 years and older.

- ECOG Performance status less than or equal to 2.

- Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets
greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5
times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to
60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria:

- Receipt of an investigational agent within 30 days.

- Allergy to ALA or similar compounds.

- Personal or family history of porphyria.

- Uncontrolled intercurrent illness.

- Inability to comply with the protocol.

- Pregnancy, breastfeeding.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to disease progression after initial surgery.

Outcome Description:

Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

William Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MultiCare Health System

Authority:

United States: Food and Drug Administration

Study ID:

ALA 11.07

NCT ID:

NCT01351519

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Malignant Glioma
  • Glioma
  • Glioblastoma
  • Glioblastoma Multiforme
  • Astrocytoma
  • Glioma
  • Glioblastoma
  • Glioblastoma Multiforme
  • Astrocytoma
  • Brain Tumor
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Glioma

Name

Location
MultiCare Health System Research Institute Tacoma, Washington  98405