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Completed

NCT Number: NCT00492089

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

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.

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Key information

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 Astrocytoma Brain Diseases Brain Neoplasms Carcinoma Carcinoma, Squamous Cell Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Cranial Nerve Diseases Ependymoma Esthesioneuroblastoma, Olfactory Glioma Head and Neck Neoplasms Hemangiopericytoma, Malignant Malignant Neoplasm Meningeal Melanocytoma Meningeal Neoplasms Meningioma Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Oligodendroglioma Pinealoma Radiation Injuries 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 Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck 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 Stomatognathic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. Determine to what extent bevacizumab can reduce active radiation toxicity to the CNS in patients who have undergone cranial irradiation for primary brain neoplasm, meningioma, or head and neck cancer.

SECONDARY OBJECTIVES:

I. Determine to what extent this drug can reduce dexamethasone dependence in these patients.

II. Determine to what extent this drug can improve neurologic function in these patients.

III. Determine to what extent this drug can improve quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled, crossover, double-blind study. Patients are randomized to 1 of 2 treatment arms.

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.

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.

Patients in arm II who have failed to respond to treatment at 6 or 12 weeks may cross over to arm I and receive 2 courses of bevacizumab as in arm I. Patients in arm I (including crossover patients) who have responded to treatment may receive 2 additional courses of bevacizumab.

Patients undergo MRI after courses 2 and 4.

Quality of life and neurologic function are assessed at baseline, periodically during study treatment, and at 12 and 24 weeks after completion of study treatment.

After completion of study treatment, patients are followed at 12 and 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No evidence of bleeding diathesis or coagulopathy
  • Fertile patients must use effective contraception during and for >= 2 months after completion of study therapy
  • No diarrhea >= grade 1
  • Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer [WHO grade 2 or 3 disease--no WHO grade 4 primary brain neoplasms (i.e., glioblastoma or gliosarcoma)]
  • Patients with head and neck cancer must not have any of the following:
  • Evidence of metastatic disease
  • Evidence of tumor invasion to major vessels (e.g., the carotid)
  • History of bleeding related to tumor or radiotherapy during or after completion of radiotherapy
  • Must have undergone cranial irradiation
  • Must have radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor within the past 2 months
  • Must have evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No evidence of active CNS hemorrhage
  • Karnofsky performance status 60-100%
  • No clinically significant cardiovascular disease, including any of the following:
  • Inadequately controlled hypertension (i.e., systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg despite antihypertensive medication)
  • Large vessel cerebrovascular accident within the past 6 months
  • Myocardial infarction or unstable angina within the past 6 months
  • No clinically significant cardiovascular disease, including any of the following:
  • NYHA class II-IV congestive heart failure
  • Serious or inadequately controlled cardiac arrhythmia
  • Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
  • Clinically significant peripheral vascular disease
  • At least 6 months since prior radiotherapy
  • Platelet count > 75,000/mm^3
  • Granulocyte count > 1,500/mm^3
  • Creatinine < 1.0 times ULN
  • AST < 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Prior chemotherapy for tumor allowed
  • Prior tyrosine kinase inhibitors of VEGF receptor (VEGFR) allowed
  • More than 28 days since prior and no concurrent major surgical procedure or open biopsy
  • Concurrent dexamethasone allowed provided patient is on a stable dose for >= 1 week prior to study entry
  • Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
  • In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin
  • No active bleeding or pathological condition that carries a high risk of bleeding
  • Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met: No evidence of serious or nonhealing wound, ulcer, or bone fracture
  • No concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR
  • No prior bevacizumab
  • More than 7 days since prior core biopsy
  • History of seizures allowed provided the patient is receiving anticonvulsant therapy
  • Hemoglobin >= 9.0 g/dL
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • No other concurrent investigational agents

Treatment and study plan

Bevacizumab

Drug

Given IV

Other names: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Placebo

Drug

Given IV

Other names: PLCB

Magnetic Resonance Imaging

Procedure

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

quality-of-life assessment

Procedure

Other names: quality of life assessment

Primary outcomes

  1. 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

    Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2007
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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