Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.

20 mg/kg administered once 3-5 hours prior to surgery

5-ALA (Gliolan)

Costas Hadjipanayis, MD, PhD

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.
* 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.

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

A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

NX PharmaGen

National Cancer Institute (NCI)

Constantinos Hadjipanayis

Professor and Chair, Neurosurgery

Behaviors and Mental Disorders

Meningioma

Cognitive Dysfunction

Amnesia

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Anaplastic Astrocytoma

Hypoglycemic Agents

Pioglitazone

Pioglitazone 22.5 mg daily before, during and after radiation therapy.

pioglitazone

Pioglitazone 45 mg by mouth daily before, during and after radiation therapy

Michael Chan

RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy.

PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors.

PRIMARY OBJECTIVE:

I. To evaluate the tolerability and toxicity associated with two different dose regimens of pioglitazone administered orally as a cytoprotective agent against radiation-induced brain injury.

SECONDARY OBJECTIVE:

I. To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients.

OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone hydrochloride once daily before for 1 week prior to brain irradiation, during and and continuing for 6 months after completion of radiation radiotherapy. After completion of study treatment, patients are followed periodically.

Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors

Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction

Wake Forest University Health Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery	NCT01445691	Benign Neoplasm... Brain Cancer Brain Neoplasms... Brain Neoplasms... Brain Tumor, Pr... Brain Tumor, Re... Brain Tumors Intracranial Ne... Neoplasms, Brai... Neoplasms, Intr... Primary Brain N... Primary Maligna... Primary Maligna... Gliomas Glioblastoma	5-ALA (Gliolan)	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai
Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors	NCT01151670	Brain Neoplasms... Brain Neoplasms... Malignant Menin... Glioblastoma Mu... Anaplastic Astr...	pioglitazone Pioglitazone	18 Years -	Wake Forest University Health Sciences

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