Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00492089 |
RATIONALE: Bevacizumab may reduce CNS side effects caused by radiation therapy.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition Head and Neck Cancer Sarcoma |
Drug: bevacizumab Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized Phase 2 Trial of Bevacizumab to Control Brain Radiation Damage |
Estimated Enrollment: | 16 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
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.
|
Drug: bevacizumab
Given IV
|
Arm II: Placebo Comparator
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.
|
Drug: placebo
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, crossover, double-blind study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer
WHO grade 2 or 3 disease
Patients with head and neck cancer must not have any of the following:
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Victor A. Levin, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000553135, MDA-2006-0890 |
Study First Received: | June 25, 2007 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00492089 |
Health Authority: | Unspecified |
adult mixed glioma adult grade II meningioma adult grade III meningioma stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx |
stage I adenoid cystic carcinoma of the oral cavity stage I basal cell carcinoma of the lip stage I mucoepidermoid carcinoma of the oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage I verrucous carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity stage II basal cell carcinoma of the lip stage II mucoepidermoid carcinoma of the oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage II 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 mucoepidermoid carcinoma of the oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage III verrucous carcinoma of the oral cavity |
Choroid Plexus Neoplasms Meningeal Neoplasms Malignant mesenchymal tumor Squamous cell carcinoma Bevacizumab Central Nervous System Neoplasms Adenoid cystic carcinoma Ependymoma Soft tissue sarcomas Carcinoma, Adenoid Cystic Carcinoma, squamous cell Laryngeal carcinoma Meningioma Glioma Choroid Plexus neoplasms |
Papilloma Salivary Gland Diseases Nervous System Neoplasms Astrocytoma Carcinoma, Basal Cell Granuloma Hemangiopericytoma Recurrence Carcinoma Epidermoid carcinoma Brain Neoplasms Nasopharyngeal carcinoma Head and Neck Neoplasms Sarcoma Hypopharyngeal cancer |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Vascular Tissue Angiogenesis Modulating Agents Growth Inhibitors |