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Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

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ClinicalTrials.gov Identifier: NCT00121225
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 32

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
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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

Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

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

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
61
(38 to 89)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  59.4%
>=65 years
13
  40.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
12
  37.5%
Male
20
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
United States 13
Canada 19
1.Primary Outcome
Title Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Hide Description [Not Specified]
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Time to Progression Assessed by RECIST
Hide Description [Not Specified]
Time Frame Up to 5 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Effect of Vorinostat on HP1 and macroH2A Nuclear Foci
Hide Description Compared with Fisher’s exact test to determine utility as biomarkers of response.
Time Frame Baseline and day 15
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Incidence of p53 Allelic Variations (72R or 72P)
Hide Description Compared using Fisher’s exact test with response.
Time Frame Baseline
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Effect of Vorinostat on Serum Levels of VEGF and b-FGF
Hide Description [Not Specified]
Time Frame Baseline, day 8 and day 15
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Indicates events were collected by systematic assessment and are reported regardless of attribution to agent.
 
Arm/Group Title Arm I
Hide Arm/Group Description

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

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   9/32 (28.13%) 
Blood and lymphatic system disorders   
Anemia   2/32 (6.25%) 
Gastrointestinal disorders   
Dry mouth   1/32 (3.13%) 
Gastric hemorrhage   1/32 (3.13%) 
Investigations   
Platelet count decreased   1/32 (3.13%) 
Metabolism and nutrition disorders   
Anorexia   1/32 (3.13%) 
Hypokalemia   1/32 (3.13%) 
Dehydration   1/32 (3.13%) 
Hyperglycemia   1/32 (3.13%) 
Musculoskeletal and connective tissue disorders   
Back pain   2/32 (6.25%) 
Myalgia   1/32 (3.13%) 
Generalized muscle weakness   1/32 (3.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain   1/32 (3.13%) 
Nervous system disorders   
Dizziness   1/32 (3.13%) 
Intracranial hemorrhage  [1]  1/32 (3.13%) 
Renal and urinary disorders   
Acute kidney injury   2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/32 (6.25%) 
Hypoxia   1/32 (3.13%) 
Vascular disorders   
Vascular disorders - Other, specify   1/32 (3.13%) 
Thromboembolic event   1/32 (3.13%) 
Indicates events were collected by systematic assessment
[1]
unrelated to study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%)
Total   32/32 (100.00%) 
Blood and lymphatic system disorders   
Anemia   20/32 (62.50%) 
General disorders   
Fatigue   28/32 (87.50%) 
Metabolism and nutrition disorders   
Hyperglycemia   24/32 (75.00%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Dr. David Hogg
Organization: Princess Margaret Cancer Centre
Phone: 416-946-4501 ext 4521
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121225     History of Changes
Other Study ID Numbers: NCI-2009-00099
PHL-040 ( Other Grant/Funding Number: N01CM62203 )
CDR0000436851 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2005
First Posted: July 21, 2005
Results First Submitted: October 1, 2014
Results First Posted: October 3, 2014
Last Update Posted: October 3, 2014