Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00324870
First received: May 10, 2006
Last updated: December 10, 2015
Last verified: October 2013
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Drug: vorinostat
Drug: bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Arm I

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV


Participant Flow:   Overall Study
    Arm I  
STARTED     37  
COMPLETED     37  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Arm I

Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.

Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.

vorinostat: Given orally

bevacizumab: Given IV


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  37  
Age  
[units: years]
Median (Full Range)
  64   (34 to 82)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     17  
Gender  
[units: participants]
 
Female     6  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     37  



  Outcome Measures

1.  Primary:   Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)   [ Time Frame: At 6 months ]

2.  Other Pre-specified:   Maximum Tolerated Dose   [ Time Frame: 18 months from first patient dosing ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Other Pre-specified:   Clinical Response Rate of SAHA and Bevacizumab   [ Time Frame: 7 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 more than 60 days but less than or equal to 180 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: Michael Carducci, MD
Organization: Johns Hopkins University
phone: 410-614-6337
e-mail: carducci@jhmi.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324870     History of Changes
Other Study ID Numbers: NCI-2009-00093
NCI-2009-00093 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NA 00001107
NCI-6884
JHOC-J0570
CDR0000467800
6884
JHOC-00001107
J0570
IRB #NA 00001107, SKCCC J0570 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
6884 ( Other Identifier: CTEP )
P30CA006973 ( US NIH Grant/Contract Award Number )
U01CA062491 ( US NIH Grant/Contract Award Number )
U01CA070095 ( US NIH Grant/Contract Award Number )
Study First Received: May 10, 2006
Results First Received: August 10, 2015
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration