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Trial record 52 of 146 for:    epilepsy AND Bethesda

Bevacizumab and Irinotecan to Treat Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393094
Recruitment Status : Terminated (Terminated due to the limitations of accrual.)
First Posted : October 26, 2006
Results First Posted : July 6, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition High-Grade Gliomas
Interventions Biological: Bevacizumab
Drug: Irinotecan hydrochloride
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enrollment Until Prior to Treatment
Hide Arm/Group Description [Not Specified]
Period Title: Period1Bevacizumab & Irinotecan Patients
Started 31
Completed 30
Not Completed 1
Reason Not Completed
Disease progression before treatment             1
Period Title: Disease Progression After Trtmt: Onstudy
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Refused further treatment             1
Arm/Group Title Enrollment Until Prior to Treatment
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  96.8%
>=65 years
1
   3.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
46.96  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
12
  38.7%
Male
19
  61.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
30
  96.8%
Unknown or Not Reported
1
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.2%
White
29
  93.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Radiographic Response Rate (Malignant Glioma Participants)
Hide Description Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Time Frame 23 months (date of first enrollment to 1 month after last progression)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Arm/Group Title Enrollment Until Prior to Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percent of participants
Partial response 0
Complete response 0
Stable disease 16.7
Progressive disease 83.3
2.Primary Outcome
Title Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.
Hide Description Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.
Time Frame 23 months (date of first enrollment to 1 month after last progression)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Arm/Group Title Enrollment Until Prior to Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
27
3.Primary Outcome
Title Radiographic Response Rate (Anaplastic Glioma Participants)
Hide Description Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Time Frame 23 months (date of first enrollment to 1 month after last progression)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Arm/Group Title Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment
Hide Arm/Group Description:
Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percent of participants
Partial response 0
Complete response 0
Stable disease 30
Progressive disease 70
4.Primary Outcome
Title Radiographic Response Rate (Glioblastoma Multiforme Participants)
Hide Description Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Time Frame 23 months (date of first enrollment to 1 month after last progression)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment
Hide Arm/Group Description:
Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Percent of participants
Partial response 0
Complete response 0
Stable disease 10
Progressive disease 90
Time Frame 23 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrollment Until Prior to Treatment
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Enrollment Until Prior to Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Enrollment Until Prior to Treatment
Affected / at Risk (%) # Events
Total   9/30 (30.00%)    
Blood and lymphatic system disorders   
Leukocytes (total white blood count (WBC))  1  1/30 (3.33%)  2
Lymphopenia  1  1/30 (3.33%)  2
Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))  1  1/30 (3.33%)  3
DIC (disseminated intravascular coagulation)  1  1/30 (3.33%)  1
General disorders   
Death not associated with CTCAE term: Death Progression NOS  1  1/30 (3.33%)  1
Investigations   
Hemoglobin  1  2/30 (6.67%)  2
Metabolism and nutrition disorders   
Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT)  1  1/30 (3.33%)  1
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)  1  1/30 (3.33%)  1
Nervous system disorders   
Neurology: Seizure  1  5/30 (16.67%)  5
Renal and urinary disorders   
Renal Failure  1  1/30 (3.33%)  1
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/30 (3.33%)  1
Hypotension  1  1/30 (3.33%)  1
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 0%
Enrollment Until Prior to Treatment
Affected / at Risk (%) # Events
Total   27/30 (90.00%)    
Blood and lymphatic system disorders   
Hemorrhage, central nervous system (CNS)  1  1/30 (3.33%)  1
Hemorrhage, genitourinary (GU) retroperitoneum  1  1/30 (3.33%)  1
Hemorrhage, pulmonary/upper respiratory: Nose  1  3/30 (10.00%)  3
Gastrointestinal disorders   
Diarrhea  1  9/30 (30.00%)  10
Nausea  1  10/30 (33.33%)  13
Vomiting  1  5/30 (16.67%)  5
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  18/30 (60.00%)  22
Cytokine release syndrome/acute infusion reaction  1  2/30 (6.67%)  2
Investigations   
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  5/30 (16.67%)  6
Alkaline phosphatase  1  2/30 (6.67%)  2
Bilirubin (hyperbilirubinemia)  1  2/30 (6.67%)  3
Hemoglobin  1  3/30 (10.00%)  3
Leukocytes (total WBC)  1  9/30 (30.00%)  12
Lymphopenia  1  1/30 (3.33%)  3
Neutrophils/granulocytes (ANC/AGC)  1  5/30 (16.67%)  13
Platelets  1  5/30 (16.67%)  9
Metabolism and nutrition disorders   
Phosphate, serum-low (hypophosphatemia)  1  7/30 (23.33%)  12
Anorexia  1  1/30 (3.33%)  2
Nervous system disorders   
Pain: head/headache  1  3/30 (10.00%)  3
Renal and urinary disorders   
Proteinuria  1  3/30 (10.00%)  3
Respiratory, thoracic and mediastinal disorders   
Hiccoughs (hiccups, singultus)  1  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body)  1  1/30 (3.33%)  1
Ulceration  1  1/30 (3.33%)  1
Vascular disorders   
Hypertension  1  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Evaluating combination therapy, 19 GBM patients were enrolled. Accrual was terminated after it became clear that we could not reach our efficacy rule of 3 or more of 29 patients responding. The AG arm never fully accrued before the study was closed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Howard A. Fine, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-402-6383
EMail: hfine@mail.nih.gov
Layout table for additonal information
Responsible Party: Howard A. Fine, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00393094     History of Changes
Other Study ID Numbers: 060250
06-C-0250
First Submitted: October 25, 2006
First Posted: October 26, 2006
Results First Submitted: March 27, 2012
Results First Posted: July 6, 2012
Last Update Posted: July 13, 2012