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A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

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ClinicalTrials.gov Identifier: NCT00606008
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : October 31, 2012
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Astrocytoma
Glioblastoma
Intervention Drug: Sunitinib Malate
Enrollment 30
Recruitment Details Patients must have had pathologically or neuroradiographically recurrent AA or GB and prior pathologic confirmation of primary tumor histology. Patients with prior low-grade glioma were eligible if histological transformation to malignant astrocytic gliomas (MAG) was confirmed before enrollment.
Pre-assignment Details Study patients were stratified by tumor histology (AAor GB).
Arm/Group Title Sutent Treatment
Hide Arm/Group Description

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Period Title: Overall Study
Started 30
Completed 25
Not Completed 5
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             4
Arm/Group Title Sutent Treatment
Hide Arm/Group Description

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  86.7%
>=65 years
4
  13.3%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
52
(30.0 to 77.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse
Hide Description Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sutent Treatment AA Cohort Patients GB Cohort Patients
Hide Arm/Group Description:

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Recurrent glioblastoma (GB) patients
Anaplastic astrocytoma (AA)patients
Overall Number of Participants Analyzed 30 14 16
Measure Type: Number
Unit of Measure: Participants
4 2 2
2.Secondary Outcome
Title Best Overall Response
Hide Description To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sutent Treatment AA Cohort Patients GB Cohort Patients
Hide Arm/Group Description:

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Recurrent glioblastoma (GB) patients
Anaplastic astrocytoma (AA)patients
Overall Number of Participants Analyzed 30 14 16
Measure Type: Number
Unit of Measure: Participants
13 8 5
3.Secondary Outcome
Title Number of Participants With Related Grade 3 and Greater Adverse Events
Hide Description To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sutent Treatment AA Cohort Patients GB Cohort Patients
Hide Arm/Group Description:

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Recurrent glioblastoma (GB) patients
Anaplastic astrocytoma (AA)patients
Overall Number of Participants Analyzed 30 14 16
Measure Type: Number
Unit of Measure: Participants
11 6 5
Time Frame 4 years, 8 months
Adverse Event Reporting Description Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/> Grade 3 toxicities associated with sunitinib.
 
Arm/Group Title Sutent Treatment AA Cohort Patients GB Cohort Patients
Hide Arm/Group Description

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.

Recurrent glioblastoma (GB) patients Anaplastic astrocytoma (AA)patients
All-Cause Mortality
Sutent Treatment AA Cohort Patients GB Cohort Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sutent Treatment AA Cohort Patients GB Cohort Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/30 (36.67%)      6/14 (42.86%)      5/16 (31.25%)    
Blood and lymphatic system disorders       
Leukocytes (total WBC)  1  3/30 (10.00%)  3/14 (21.43%)  0/16 (0.00%) 
Lymphopenia  1  1/30 (3.33%)  1/14 (7.14%)  0/16 (0.00%) 
Platelets  1  4/30 (13.33%)  2/14 (14.29%)  2/16 (12.50%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/30 (3.33%)  0/14 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders       
Mucositis/stomatitis (functional/symptomatic) - anus  1  1/30 (3.33%)  0/14 (0.00%)  1/16 (6.25%) 
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  3/30 (10.00%)  1/14 (7.14%)  2/16 (12.50%) 
Death not associated with CTCAE term - disease progression NOS  1  1/30 (3.33%)  1/14 (7.14%)  0/16 (0.00%) 
Hemorrhage/bleeding—other  1  1/30 (3.33%)  1/14 (7.14%)  0/16 (0.00%) 
Metabolism and nutrition disorders       
ALT, SGPT  1  1/30 (3.33%)  0/14 (0.00%)  1/16 (6.25%) 
AST, SGOT  1  1/30 (3.33%)  0/14 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Dermatology/skin—other  1  1/30 (3.33%)  1/14 (7.14%)  0/16 (0.00%) 
Rash: hand-foot skin reaction  1  2/30 (6.67%)  2/14 (14.29%)  0/16 (0.00%) 
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%
Sutent Treatment AA Cohort Patients GB Cohort Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/30 (93.33%)      14/14 (100.00%)      14/16 (87.50%)    
Blood and lymphatic system disorders       
Lymphatics - other  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Leukocytes (total WBC)  1  5/30 (16.67%)  7 3/14 (21.43%)  5 2/16 (12.50%)  2
Neutrophils/granulocytes (ANC/AGC)  1  7/30 (23.33%)  13 4/14 (28.57%)  6 3/16 (18.75%)  7
Platelets  1  6/30 (20.00%)  6 3/14 (21.43%)  3 3/16 (18.75%)  3
Lymphopenia  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Hemoglobin  1  3/30 (10.00%)  5 2/14 (14.29%)  2 1/16 (6.25%)  3
Edema: limb  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Blood/Bone Marrow - Other  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Cardiac disorders       
Hypertension  1  3/30 (10.00%)  3 1/14 (7.14%)  1 2/16 (12.50%)  2
Ear and labyrinth disorders       
Hearing: patients without baseline audiogram and not enrolled n a monitoring program  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Endocrine disorders       
Hot flashes/flushes  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Eye disorders       
Vision - Blurred vision  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  1
Ocular/Visual - Other  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Pain - Eye  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  7/30 (23.33%)  8 2/14 (14.29%)  2 5/16 (31.25%)  6
Anorexia  1  4/30 (13.33%)  4 3/14 (21.43%)  3 1/16 (6.25%)  1
Gastrointestinal - other  1  3/30 (10.00%)  3 1/14 (7.14%)  1 2/16 (12.50%)  2
Heartburn/dyspepsia  1  3/30 (10.00%)  4 1/14 (7.14%)  1 2/16 (12.50%)  3
Nausea  1  7/30 (23.33%)  8 5/14 (35.71%)  6 2/16 (12.50%)  2
Vomiting  1  7/30 (23.33%)  7 4/14 (28.57%)  4 3/16 (18.75%)  3
Diarrhea  1  15/30 (50.00%)  16 7/14 (50.00%)  8 8/16 (50.00%)  8
Mucositis/stomatitis (clinical exam) - Oral cavity  1  5/30 (16.67%)  6 2/14 (14.29%)  2 3/16 (18.75%)  4
Flatulence  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Perforation, GI - Rectum  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Dysphagia (difficulty swallowing)  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Mucositis/stomatitis (functional/symptomatic) - Stomach  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  21/30 (70.00%)  27 11/14 (78.57%)  12 10/16 (62.50%)  15
Confusion  1  4/30 (13.33%)  5 3/14 (21.43%)  3 1/16 (6.25%)  2
Mood alteration - Depression  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Pain - Back  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  1
Weight loss  1  4/30 (13.33%)  4 2/14 (14.29%)  2 0/16 (0.00%)  0
Cognitive disturbance  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  2
Insomnia  1  2/30 (6.67%)  2 2/14 (14.29%)  2 0/16 (0.00%)  0
Pain - Abdomen NOS  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Pain - Other  1  3/30 (10.00%)  3 1/14 (7.14%)  1 2/16 (12.50%)  2
Pain - Stomach  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Sweating (diaphoresis)  1  4/30 (13.33%)  5 2/14 (14.29%)  2 2/16 (12.50%)  3
Rigors/chills  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Pain - Extremity-limb  1  2/30 (6.67%)  3 1/14 (7.14%)  1 1/16 (6.25%)  2
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Pain - Chest wall  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Mood alteration - Agitation  1  5/30 (16.67%)  5 3/14 (21.43%)  3 2/16 (12.50%)  2
Hemorrhage/Bleeding - Other  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Immune system disorders       
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  3/30 (10.00%)  5 1/14 (7.14%)  3 2/16 (12.50%)  2
Allergy/Immunology - Other  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  1
Allergic reaction/hypersensitivity (including drug fever)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Infections and infestations       
Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Infection with unknown ANC - Oral cavity-gums (gingivitis)  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders       
Glucose, serum-high (hyperglycemia)  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  1
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity - lower  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity - upper  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Pain - Joint  1  5/30 (16.67%)  6 3/14 (21.43%)  4 2/16 (12.50%)  2
Muscoleoskeletal/Soft Tissue - Other  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Pain - Muscle  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Nervous system disorders       
Ataxia (incoordination)  1  3/30 (10.00%)  3 3/14 (21.43%)  3 0/16 (0.00%)  0
Neuropathy: cranial - CN IV Downward, inward movement of eye  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Neuropathy: cranial - CN II Vision  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Neuropathy: motor  1  11/30 (36.67%)  13 5/14 (35.71%)  6 6/16 (37.50%)  7
Neuropathy: sensory  1  8/30 (26.67%)  10 5/14 (35.71%)  6 3/16 (18.75%)  4
Speech impairment (e.g., dysphasia or aphasia)  1  5/30 (16.67%)  5 2/14 (14.29%)  2 3/16 (18.75%)  3
Pain - Head/headache  1  8/30 (26.67%)  10 2/14 (14.29%)  3 6/16 (37.50%)  7
Seizure  1  3/30 (10.00%)  4 2/14 (14.29%)  3 1/16 (6.25%)  1
Dizziness  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Neuropathy: cranial - CN VII Motor-face; Sensory-taste  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Somnolence/depressed level of consciousness  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Neuropathy: cranial - CN I Smell  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Hemorrhage, CNS  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Tremor  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Neurology - Other  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Renal and urinary disorders       
Urinary frequency/urgency  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Renal/Genitourinary - Other  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders       
Hiccoughs (hiccups, singultus)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Cough  1  3/30 (10.00%)  3 1/14 (7.14%)  1 2/16 (12.50%)  2
Infection with unknown ANC - Lung pneumonia)  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders       
Dermatology/Skin - other  1  7/30 (23.33%)  9 4/14 (28.57%)  5 3/16 (18.75%)  4
Hair loss/alopecia (scalp or body)  1  3/30 (10.00%)  3 2/14 (14.29%)  2 1/16 (6.25%)  1
Rash: hand-foot skin reaction  1  4/30 (13.33%)  5 3/14 (21.43%)  3 1/16 (6.25%)  2
Urticaria (hives, welts, wheals)  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Dry skin  1  2/30 (6.67%)  2 0/14 (0.00%)  0 2/16 (12.50%)  2
Pruritus/itching  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Hypopigmentation  1  3/30 (10.00%)  3 3/14 (21.43%)  3 0/16 (0.00%)  0
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  2/30 (6.67%)  2 1/14 (7.14%)  1 1/16 (6.25%)  1
Rash: acne/acneiform  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Photosensitivity  1  1/30 (3.33%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Rash/desquamation  1  4/30 (13.33%)  6 2/14 (14.29%)  4 2/16 (12.50%)  2
Flushing  1  1/30 (3.33%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
No definitive conclusions can be made regarding outcome differences between bevacizumab vs. bevacizumab-naive study patients, due to not enough patients who received bevacizumab prior to study enrollment (2 AA, 3 GB).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Edward Pan
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3871
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00606008     History of Changes
Other Study ID Numbers: MCC-14916
First Submitted: January 21, 2008
First Posted: February 1, 2008
Results First Submitted: October 2, 2012
Results First Posted: October 31, 2012
Last Update Posted: November 19, 2012