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Trial record 37 of 228 for:    "Anaplastic oligodendroglioma"

Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors

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ClinicalTrials.gov Identifier: NCT00667394
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : August 31, 2012
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Mixed Oligoastrocytoma
Interventions Biological: Bevacizumab
Drug: MLN-518 (Tandutinib)
Procedure: Quality-of-life assessment
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Hide Arm/Group Description GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks. AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
Period Title: Overall Study
Started 41 1
Completed 37 1
Not Completed 4 0
Reason Not Completed
Adverse Event             3             0
Progressive disease             1             0
Arm/Group Title Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients Total
Hide Arm/Group Description GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks. AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 41 1 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 1 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
  87.8%
1
 100.0%
37
  88.1%
>=65 years
5
  12.2%
0
   0.0%
5
  11.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 1 participants 42 participants
54.16  (11.52) 63  (0) 54.37  (11.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 1 participants 42 participants
Female
12
  29.3%
0
   0.0%
12
  28.6%
Male
29
  70.7%
1
 100.0%
30
  71.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 1 participants 42 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
38
  92.7%
1
 100.0%
39
  92.9%
Unknown or Not Reported
3
   7.3%
0
   0.0%
3
   7.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 1 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.3%
0
   0.0%
3
   7.1%
Native Hawaiian or Other Pacific Islander
1
   2.4%
0
   0.0%
1
   2.4%
Black or African American
3
   7.3%
0
   0.0%
3
   7.1%
White
32
  78.0%
1
 100.0%
33
  78.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.9%
0
   0.0%
2
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 1 participants 42 participants
41 1 42
1.Primary Outcome
Title Progression-free Survival at 6 Months
Hide Description Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Hide Arm/Group Description:
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
Overall Number of Participants Analyzed 37 0
Median (95% Confidence Interval)
Unit of Measure: Percentage of participants
23
(12 to 37)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 45 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Hide Arm/Group Description:
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
Overall Number of Participants Analyzed 41 1
Measure Type: Number
Unit of Measure: Participants
40 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Hide Arm/Group Description GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks. AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
All-Cause Mortality
Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/41 (36.59%)      0/1 (0.00%)    
Gastrointestinal disorders     
Nausea  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Perforation, GI::Stomach  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Perforation, GI::Colon  1  1/41 (2.44%)  1 0/1 (0.00%)  0
General disorders     
Death not associated with CTCAE term: Death Progression NOS  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Infections and infestations     
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Pleura (empyema)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Infection with unknown ANC::Lung (pneumonia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Investigations     
Platelets  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Prolonged QTc interval  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Pain-Other (Specify, lower extremities)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Nervous system disorders     
Hemorrhage, CNS  1  3/41 (7.32%)  3 0/1 (0.00%)  0
Pain::Head/headache  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Seizure  1  5/41 (12.20%)  7 0/1 (0.00%)  0
Psychiatric disorders     
Psychosis (hallucinations/delusions)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other (Specify, keratosis & dermal hematoma)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Rash: hand-foot skin reaction  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Vascular disorders     
Hypertension  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Thrombosis/thrombus/embolism  1  1/41 (2.44%)  1 0/1 (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 0%
Tandutinib & Bevacizumab in GBM Patients Tandutinib & Bevacizumab in AG Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/41 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders     
Blood/Bone marrow - Other (Specify, elevated eosinophils)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Cardiac disorders     
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Eye disorders     
Hemorrhage/Bleeding - Other (hemorrhage into sclera)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Keratitis (corneal inflammatory/corneal ulceration)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Muscle weakness, generalized or specific area (not due to neuropathy)::Extraocular  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Vision-blurred vision  1  4/41 (9.76%)  4 0/1 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  31/41 (75.61%)  40 1/1 (100.00%)  1
Dry mouth/salivary gland (xerostomia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Dysphagia (difficulty swallowing)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Gastritis (including bile reflux gastritis)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Hemorrhage, GI::Anus  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Hemorrhage, GI::Rectum  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Nausea  1  22/41 (53.66%)  27 1/1 (100.00%)  1
Vomiting  1  6/41 (14.63%)  6 0/1 (0.00%)  0
General disorders     
Edema::head and neck  1  17/41 (41.46%)  21 0/1 (0.00%)  0
Edema: limb  1  9/41 (21.95%)  9 0/1 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  21/41 (51.22%)  30 0/1 (0.00%)  0
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Infections and infestations     
Infection with unknown ANC::Lip/perioral  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Wound complication, non-infectious  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  4/41 (9.76%)  6 0/1 (0.00%)  0
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  16/41 (39.02%)  26 0/1 (0.00%)  0
Alkaline phosphatase  1  6/41 (14.63%)  7 0/1 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  4/41 (9.76%)  6 0/1 (0.00%)  0
Creatinine  1  2/41 (4.88%)  4 1/1 (100.00%)  1
Hemoglobin  1  14/41 (34.15%)  22 1/1 (100.00%)  2
Leukocytes (total WBC)  1  21/41 (51.22%)  69 0/1 (0.00%)  0
Lymphopenia  1  23/41 (56.10%)  73 0/1 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  13/41 (31.71%)  49 0/1 (0.00%)  0
Platelets  1  17/41 (41.46%)  31 0/1 (0.00%)  0
Prolonged QTc interval  1  21/41 (51.22%)  51 0/1 (0.00%)  0
Weight gain  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Weight loss  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Anorexia  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Calcium, serum-high (hypercalcemia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Dehydration  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Glucose, serum-low (hyperglycemia)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Magnesium, serum-high (hypermagnesemia)  1  6/41 (14.63%)  6 0/1 (0.00%)  0
Magnesium, serum-low (hypomagnesemia)  1  1/41 (2.44%)  4 0/1 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  15/41 (36.59%)  35 1/1 (100.00%)  3
Sodium, serum-low (hypernatremia)  1  3/41 (7.32%)  4 0/1 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower  1  3/41 (7.32%)  5 0/1 (0.00%)  0
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized  1  7/41 (17.07%)  12 0/1 (0.00%)  0
Pain::Other (Specify, left arm (phlebotomy pain))  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Pain::Chest wall  1  3/41 (7.32%)  3 0/1 (0.00%)  0
Pain::Muscle  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Pain::Neck  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Pain::Head/headache  1  6/41 (14.63%)  7 0/1 (0.00%)  0
Pyramidal tract dysfunction (e.g., increased tone, hyperflexia, positive Babinski, decreased fine mo  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Renal and urinary disorders     
Hemoglobinuria  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Proteinuria  1  18/41 (43.90%)  21 1/1 (100.00%)  2
Urinary frequency/urgency  1  2/41 (4.88%)  4 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hemorrhage, pulmonary/upper respiratory::Nose  1  1/41 (2.44%)  1 1/1 (100.00%)  1
Pain::Throat/pharynx/larynx  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other (Specify,hyperpigmentation 1; laceration)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Hair loss/alopecia (scalp or body)  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Hypopigmentation  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Nail changes  1  2/41 (4.88%)  2 0/1 (0.00%)  0
Rash/desquamation  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Rash: acne/acneiform  1  6/41 (14.63%)  6 0/1 (0.00%)  0
Rash: hand-foot skin reaction  1  3/41 (7.32%)  3 0/1 (0.00%)  0
Vascular disorders     
Flushing  1  1/41 (2.44%)  1 0/1 (0.00%)  0
Hypertension  1  16/41 (39.02%)  24 1/1 (100.00%)  1
Lymphedema-related fibrosis  1  1/41 (2.44%)  1 0/1 (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 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
Name/Title: Dr. Katherine Warren
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-435-4683
Responsible Party: Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00667394     History of Changes
Other Study ID Numbers: 080101
08-C-0101
First Submitted: April 25, 2008
First Posted: April 28, 2008
Results First Submitted: July 30, 2012
Results First Posted: August 31, 2012
Last Update Posted: November 5, 2015