More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

Condition(s) targeted: 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

Intervention: 5-ALA (Gliolan) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Costas Hadjipanayis, MD, PhD, Principal Investigator, Affiliation: Emory University Winship Cancer Institute

Overall contact:
Costas Hadjipanayis, MD, PhD, Phone: 1-888-946-7447, Email: chadjip@emory.edu

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, and

- 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.

Official title: WCI1999-11: A Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

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

Primary outcome: Radicality of Brain Tumor Resection

Secondary outcome: Progression-free survival every 3 months after surgery

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients 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. Sixty (60) newly diagnosed and recurrent malignant gliomas will be enrolled in this 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.

- ECOG performance status <2 (Karnofsky >60%, see Appendix A).

- 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.

- 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.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Prior therapy is not an exclusion criterion.

- Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI

- Patients 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 h.

- Personal or family history of porphorias.

- 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)

- Inclusion of Women and Minorities: Both men and women and members of all ethnic

groups are eligible for this trial.

Costas Hadjipanayis, MD, PhD, Phone: 1-888-946-7447, Email: chadjip@emory.edu

Emory University Hospital Midtown, Atlanta, Georgia 30322, United States; Recruiting
Stephanie Mcmillan, Email: sjmcmil@emory.edu

Starting date: September 2011
Last updated: October 18, 2012