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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

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ClinicalTrials.gov Identifier: NCT00492089
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : June 14, 2013
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Supportive Care
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
Drug: placebo
Procedure: magnetic resonance imaging
Procedure: quality-of-life assessment
Enrollment 11
Recruitment Details Recruitment Period: June 20, 2007 to December 07, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Of the 15 patients enrolled, four participants were excluded from the study.
Arm/Group Title Arm A: Bevacizumab Crossover Arm B: Placebo First, Then Bevacizumab
Hide Arm/Group Description Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks. Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
Period Title: First Intervention (6 Weeks)
Started 5 6
Completed 5 6
Not Completed 0 0
Period Title: Second Intervention (6 Weeks)
Started 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title Arm A: Bevacizumab Crossover Arm B: Placebo First, Then Bevacizumab Total
Hide Arm/Group Description Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
43
(39 to 59)
47
(39 to 70)
47
(39 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
3
  60.0%
3
  50.0%
6
  54.5%
Male
2
  40.0%
3
  50.0%
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
Hide Description 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.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.
Arm/Group Title Arm A: Bevacizumab Crossover Arm B: Placebo Then Bevacizumab
Hide Arm/Group Description:
Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: participants
5 6
Time Frame 2 years and 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab Placebo
Hide Arm/Group Description Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks First Intervention Placebo IV (only) every 3 weeks for two courses
All-Cause Mortality
Bevacizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      0/6 (0.00%)    
Gastrointestinal disorders     
Dysphagia  1  1/11 (9.09%)  2 0/6 (0.00%)  0
Nervous system disorders     
Seizure  1  1/11 (9.09%)  1 0/6 (0.00%)  0
Vascular disorders     
Thrombosis  1  2/11 (18.18%)  2 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      0/6 (0.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/11 (9.09%)  1 0/6 (0.00%)  0
Cardiac disorders     
Hypertension  1  4/11 (36.36%)  4 0/6 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  1/11 (9.09%)  1 0/6 (0.00%)  0
General disorders     
Fatigue  1  3/11 (27.27%)  3 0/6 (0.00%)  0
Hepatobiliary disorders     
Elevated alanine aminotransferase (ALT)  1  2/11 (18.18%)  2 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Monica Loghin, MD / Assistant Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: K Hunter, RN 713-745-5769
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00492089     History of Changes
Other Study ID Numbers: NCI-2009-00256
NCI-2009-00256 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000553135
2006-0890 ( Other Identifier: M D Anderson Cancer Center )
7955 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2007
First Posted: June 27, 2007
Results First Submitted: June 15, 2012
Results First Posted: June 14, 2013
Last Update Posted: May 9, 2014