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Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT01266031
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : September 23, 2016
Last Update Posted : July 3, 2018
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Genentech, Inc.
Merck Sharp & Dohme Corp.
Brain Tumor Trials Collaborative
Ohio State University Wexner Medical Center
Northwestern University Feinberg School of Medicine
UF Health Cancer Center at Orlando Health
Baylor Health Care System
MUSC Hollings Cancer Center
University of Utah Health System
University of Washington
Henry Ford Health System
Columbia University
Rush University Medical Center
NorthShore University HealthSystem
The Cleveland Clinic
University of North Carolina, Chapel Hill
Washington University School of Medicine
Texas Oncology-Austin
Information provided by (Responsible Party):
Mark Gilbert, M.D., National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Malignant Glioma
Recurrent Glioblastoma
Interventions: Drug: vorinostat
Drug: bevacizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: the study was initially written in 2010 and eventually activated at the lead site on 7/6/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vorinostat + Bevacizumab Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
Bevacizumab Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.

Participant Flow:   Overall Study
    Vorinostat + Bevacizumab   Bevacizumab   Bevacizumab + Vorinostat 400 mg
STARTED   6   41   49 
COMPLETED   6   38   47 
NOT COMPLETED   0   3   2 
Not treated                0                3                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vorinostat + Bevacizumab Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
Bevacizumab Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Total Total of all reporting groups

Baseline Measures
   Vorinostat + Bevacizumab   Bevacizumab   Bevacizumab + Vorinostat 400 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   41   49   96 
Age 
[Units: Years]
Median (Full Range)
 51.5 
 (18 to 66) 
 60 
 (27 to 88) 
 57 
 (22 to 75) 
 57 
 (18 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  50.0%      12  29.3%      18  36.7%      33  34.4% 
Male      3  50.0%      29  70.7%      31  63.3%      63  65.6% 
Region of Enrollment 
[Units: Participants]
       
United States   6   41   49   96 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS) at 6 Months   [ Time Frame: Baseline until disease progression or death due to any cause, up to six months ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab   [ Time Frame: 28 day, cycle 1 ]

3.  Secondary:   Time to Progression (TTP)   [ Time Frame: 3, 6, and 12 months from patient registration ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: up to 30 months. ]

5.  Secondary:   Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF)   [ Time Frame: Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) ]

6.  Secondary:   Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA)   [ Time Frame: Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) ]

7.  Secondary:   Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool   [ Time Frame: Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12) ]

8.  Secondary:   Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool   [ Time Frame: Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) ]

9.  Secondary:   Mean Symptom Interference at the Time of Clinical Evaluation   [ Time Frame: Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) ]

10.  Secondary:   Radiological Response   [ Time Frame: End of therapy, approximately ]

11.  Secondary:   Number of Participants With Serious and Non-Serious Adverse Events   [ Time Frame: Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mark Gilbert
Organization: National Cancer Institute
phone: 301-402-6383
e-mail: gilbertmr@mail.nih.gov



Responsible Party: Mark Gilbert, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01266031     History of Changes
Other Study ID Numbers: 999916116
16-C-N116
First Submitted: December 22, 2010
First Posted: December 24, 2010
Results First Submitted: March 15, 2016
Results First Posted: September 23, 2016
Last Update Posted: July 3, 2018