Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer

Summary

Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II trial is studying how well bevacizumab works in reducing CNS side effects in patients who have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head and neck cancer.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Meningioma
• Adult Anaplastic Oligodendroglioma
• Adult Brain Stem Glioma
• Adult Central Nervous System Germ Cell Tumor
• Adult Choroid Plexus Tumor
• Adult Diffuse Astrocytoma
• Adult Ependymoma
• Adult Grade II Meningioma
• Adult Grade III Meningioma
• Adult Malignant Hemangiopericytoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Papillary Meningioma
• Adult Pineocytoma
• Malignant Neoplasm
• Meningeal Melanocytoma
• Radiation Toxicity
• Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
• Recurrent Adult Brain Tumor
• Recurrent Basal Cell Carcinoma of the Lip
• Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Lymphoepithelioma of the Nasopharynx
• Recurrent Lymphoepithelioma of the Oropharynx
• Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
• Recurrent Salivary Gland Cancer
• Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Stage I Adenoid Cystic Carcinoma of the Oral Cavity
• Stage I Basal Cell Carcinoma of the Lip
• Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage I Lymphoepithelioma of the Nasopharynx
• Stage I Lymphoepithelioma of the Oropharynx
• Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage I Mucoepidermoid Carcinoma of the Oral Cavity
• Stage I Salivary Gland Cancer
• Stage I Squamous Cell Carcinoma of the Hypopharynx
• Stage I Squamous Cell Carcinoma of the Larynx
• Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage I Squamous Cell Carcinoma of the Nasopharynx
• Stage I Squamous Cell Carcinoma of the Oropharynx
• Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage I Verrucous Carcinoma of the Larynx
• Stage I Verrucous Carcinoma of the Oral Cavity
• Stage III Adenoid Cystic Carcinoma of the Oral Cavity
• Stage III Basal Cell Carcinoma of the Lip
• Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage III Lymphoepithelioma of the Nasopharynx
• Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage III Mucoepidermoid Carcinoma of the Oral Cavity
• Stage III Salivary Gland Cancer
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Larynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage III Verrucous Carcinoma of the Larynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
• Stage IV Basal Cell Carcinoma of the Lip
• Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Oropharynx
• Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Verrucous Carcinoma of the Larynx
• Stage IV Verrucous Carcinoma of the Oral Cavity

Interventions

DRUG

bevacizumab

Given IV

DRUG

placebo

Given IV

PROCEDURE

magnetic resonance imaging

PROCEDURE

quality-of-life assessment

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Monica Loghin · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2010-08-31

Completion

2010-08-31

Countries

• United States

Study Locations