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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — DRUG
  Given IV
• placebo — DRUG
  Given IV
• magnetic resonance imaging — PROCEDURE
• quality-of-life assessment — PROCEDURE

Study Details

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.

Key Dates

First listed

Jun 27, 2007

Start date

Jun 30, 2007

Status verified

Apr 2013

Primary completion

Aug 31, 2010

Completion

Aug 31, 2010

Study Design

Enrollment

11 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I
  Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
• Placebo Comparator: Arm II
  Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment [ Time Frame: Baseline to 12 weeks ]

Locations (1)

Find similar trials in Houston, TX

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