Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00121225
First received: July 19, 2005
Last updated: October 1, 2014
Last verified: May 2013
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Iris Melanoma
Uveal Melanoma
Recurrent Intraocular Melanoma
Recurrent Melanoma
Stage IV Melanoma
Intervention: Drug: vorinostat

  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

Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

vorinostat


Participant Flow:   Overall Study
    Arm I  
STARTED     32  
COMPLETED     32  
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

Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

vorinostat


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 38 to 89 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     13  
Gender  
[units: participants]
 
Female     12  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     13  
Canada     19  



  Outcome Measures

1.  Primary:   Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Time to Progression Assessed by RECIST   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Effect of Vorinostat on HP1 and macroH2A Nuclear Foci   [ Time Frame: Baseline and day 15 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Incidence of p53 Allelic Variations (72R or 72P)   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Effect of Vorinostat on Serum Levels of VEGF and b-FGF   [ Time Frame: Baseline, day 8 and day 15 ]
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: Dr. David Hogg
Organization: Princess Margaret Cancer Centre
phone: 416-946-4501 ext 4521
e-mail: david.hogg@uhn.ca


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121225     History of Changes
Other Study ID Numbers: NCI-2009-00099, PHL-040, CDR0000436851, N01CM62203
Study First Received: July 19, 2005
Results First Received: October 1, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration