RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

Summary

This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation therapy in treating patients with newly diagnosed malignant glioma. Enzyme inhibitors, such as gamma-secretase/Notch signalling pathway inhibitor RO4929097, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with temozolomide and radiation therapy may kill more tumor cells.

Conditions

• Acoustic Schwannoma
• Adult Anaplastic (Malignant) Meningioma
• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Brain Stem Glioma
• Adult Choroid Plexus Neoplasm
• Adult Craniopharyngioma
• Adult Diffuse Astrocytoma
• Adult Ependymoblastoma
• Adult Ependymoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Grade I Meningioma
• Adult Grade II Meningioma
• Adult Medulloblastoma
• Adult Mixed Glioma
• Adult Myxopapillary Ependymoma
• Adult Oligodendroglioma
• Adult Papillary Meningioma
• Adult Pilocytic Astrocytoma
• Adult Pineal Gland Astrocytoma
• Adult Pineoblastoma
• Adult Pineocytoma
• Adult Primary Melanocytic Lesion of Meninges
• Adult Subependymal Giant Cell Astrocytoma
• Adult Subependymoma
• Adult Supratentorial Primitive Neuroectodermal Tumor
• Malignant Adult Intracranial Hemangiopericytoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3-D conformal radiation therapy

DRUG

Gamma-Secretase Inhibitor RO4929097

Given PO

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Temozolomide

Given PO

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Antonio Omuro · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2013-06-30

Countries

• United States

Study Locations