Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Ear, Nose, and Throat Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Brain Neoplasms

Central Nervous System Neoplasms

Meningioma

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibromatosis 2

Solitary Fibrous Tumors

Hemangiopericytoma

Hemangioblastoma

Neoplasms, Fibrous Tissue

Nervous System Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Nerve Sheath Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Peripheral Nervous System Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Hemangioma

Hemangioma, Capillary

Neurofibromatosis

Neurofibromatosis Type 1

Neurofibromatosis Type 2

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Cytochrome P-450 CYP3A Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.

The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.

Thomas Kaley, MD

The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.

Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.

This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.

Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Dana-Farber Cancer Institute

University of Virginia

University of Pittsburgh

Pfizer

Memorial Sloan Kettering Cancer Center

All patients treated with Sunitinib (SU011248)

All Patients

Aggressive Memingioma

Patients with WHO grade I meningioma, HPC and hemangioblastoma

Exploratory Cohort

Total

Median Age

Age, Customized

Sex: Female, Male

Dr. Thomas Kaley

Complete Response

Partial Response

Progression of Disease

Stable Disease

Overall Objective Response

Overall Study

Glioma

Glioblastoma

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Anaplastic Oligoastrocytoma

Neuroepithelioma

Analgesics

Immunomodulating Agents

Interleukin-2

alloreactive CTL

The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.

Cellular Immunotherapy Study for Brain Cancer

A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Behaviors and Mental Disorders

Cognitive Dysfunction

Amnesia

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Brain Diseases

Central Nervous System Diseases

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
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma	NCT00589784	CNS Cancer Meningioma Intracranial He... Hemangioblastom... Neurofibromatos...	Sunitinib	18 Years -	Memorial Sloan Kettering Cancer Center
Cellular Immunotherapy Study for Brain Cancer	NCT01144247	Gliomas Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe... Glioblastoma Mu... Malignant Menin...	alloreactive CT...	18 Years -	Jonsson Comprehensive Cancer Center
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
Cellular Immunotherapy Study for Brain Cancer	NCT01144247	Gliomas Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe... Glioblastoma Mu... Malignant Menin...	alloreactive CT...	18 Years -	Jonsson Comprehensive Cancer Center
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma	NCT00589784	CNS Cancer Meningioma Intracranial He... Hemangioblastom... Neurofibromatos...	Sunitinib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for malignant meningioma