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Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00109005
First received: April 21, 2005
Last updated: September 20, 2016
Last verified: September 2016
Results First Received: August 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: Revlimid

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cohort 1 - 25 mg Lenalidomide (Revlimid) oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
Cohort 2 - 5 mg Lenalidomide (Revlimid) oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks

Participant Flow:   Overall Study
    Cohort 1 - 25 mg Lenalidomide (Revlimid)   Cohort 2 - 5 mg Lenalidomide (Revlimid)
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
Cohort 1 - 25 mg Lenalidomide (Revlimid) oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
Cohort 2 - 5 mg Lenalidomide (Revlimid) oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
Total Total of all reporting groups

Baseline Measures
   Cohort 1 - 25 mg Lenalidomide (Revlimid)   Cohort 2 - 5 mg Lenalidomide (Revlimid)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   7   15 
>=65 years   0   2   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.7  (7.6)   58.86  (9.83)   55.56  (9.71) 
Gender 
[Units: Participants]
     
Female   5   8   13 
Male   3   1   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   8   9   17 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   7   9   16 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 


  Outcome Measures
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1.  Primary:   Clinical Responses in Patients With Metastatic Ocular Melanoma   [ Time Frame: 12 months ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 24 months ]

3.  Secondary:   Progression Free Survival   [ Time Frame: up to 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: up to 2 years ]

5.  Secondary:   Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 4 mg and 25 mg   [ Time Frame: Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours. ]

6.  Secondary:   Determine Dose Level With Superior Efficacy and Acceptable Toxicity   [ Time Frame: up to 2 years ]

7.  Secondary:   Evaluate Effects of Lenalidomide on Pathways   [ Time Frame: Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy. ]


  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 NOT 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: Caryn Steakley
Organization: National Cancer Institute, National Institutes of Health
phone: 301-435-3685
e-mail: steaklec@mail.nih.gov


Publications:

Responsible Party: Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00109005     History of Changes
Obsolete Identifiers: NCT00112606
Other Study ID Numbers: 050095
05-C-0095
Study First Received: April 21, 2005
Results First Received: August 29, 2012
Last Updated: September 20, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration