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A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain


Phase 1
N/A
N/A
Not Enrolling
Both
Brain Tumors

Thank you

Trial Information

A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain


Inclusion Criteria:



- patients must have clinically documented primary brain tumor for which resection is
clinically indicated. Anticipated histology at resection should include:anaplastic
astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant,
glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma,
medulloblastoma, mixed astrocytoma-ependymoma

- prior therapy is not a consideration in protocol entry

- age unrestricted

- ECOG performance status<2(Karnofsky>60%,)

- life expectancy is not a consideration for protocol entry

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

- leukocytes _> 3,000/ml

- absolute neutrophil count _>1,500/ml

- platelets >_100,000/ml

- 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

- 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.

- 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 a written informed consent.

Exclusion Criteria:

- prior therapy is not an exclusion criterion

- patients may not be receiving any other investigational agents history of allergic
reactions attributed to compounds of similar chemical or biologic composition to
aminolevulinic adic (ALA)

- 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, breastfeeding should be discontinued if mother is
treated with aminolevulinic acid.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Establish safe dose for oral ALA administration. NCI Common Toxicity Criteria will be used to quantify toxicity following ALA administration.

Outcome Time Frame:

108 weeks

Safety Issue:

Yes

Principal Investigator

John Ruge, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Advocate Lutheran General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

4079

NCT ID:

NCT00671710

Start Date:

April 2008

Completion Date:

November 2010

Related Keywords:

  • Brain Tumors
  • malignant glial brain tumors
  • Brain Neoplasms
  • Glioma

Name

Location

Advocate Lutheran General HospitalPark Ridge, Illinois  60068