Know Cancer

or
forgot password

Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Astrocytoma, Glioma

Thank you

Trial Information

Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas


Inclusion Criteria:



- Patients must have clinically documented primary brain tumor for which resection is
clinically indicated. Radiographic findings should be consistent with high grade
glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO
Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).

- Patients must be aged greater than 18 years old

- Karnofsky Performance Score > 70 (Appendix)

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

- Leukocytes > 3,000 /uL

- Absolute neutrophil count > 1,500/uL

- Platelets > 100,000/uL

- Total bilirubin within normal institutional limits

- AST/ALT within normal institutional limits

- Creatinine within normal institutional limits

Exclusion Criteria:

- Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.

- History of allergic reactions to compounds of similar chemical composition to ALA.

- Personal or family history of porphyrias

- Personal history of hepatitis or other liver diseases.

- Pregnant women are excluded from this study because ALA is of unknown teratogenic
effects. Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with ALA, breastfeeding should be
discontinued prior to treatment with ALA.

- Inability to undergo magnetic resonance imaging (i.e. those patients with
AICD/pacemakers).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

serious adverse event (SAE) Rate

Outcome Description:

It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing): Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity

Outcome Time Frame:

2 weeks from dosing

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

J1140

NCT ID:

NCT01502605

Start Date:

Completion Date:

Related Keywords:

  • Astrocytoma
  • Glioma
  • 5-ALA
  • Aminolevulinic Acid
  • Craniotomy
  • Brain Tumor
  • Surgical Resection
  • Neurosurgery
  • Astrocytoma
  • Glioma

Name

Location

Johns Hopkins HospitalBaltimore, Maryland  21287