FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

This study has been terminated.
(The study was terminated on May 17, 2006 due to slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00104884
First received: March 3, 2005
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Malignant Melanoma
Melanoma
Intervention: Drug: Depsipeptide

  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
The study was activated on January 11, 2005, and terminated on May 17, 2006 due to slow accrual. Four patients were enrolled.

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
Depsipeptide Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.

Participant Flow:   Overall Study
    Depsipeptide  
STARTED     4  
COMPLETED     0  
NOT COMPLETED     4  
Disease progression                 4  



  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.
All enrolled patients

Reporting Groups
  Description
Depsipeptide Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.

Baseline Measures
    Depsipeptide  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median (Full Range)
  53.5   (51 to 66)  
Gender  
[units: participants]
 
Female     1  
Male     3  



  Outcome Measures

1.  Primary:   Proportion of Patients With Response to Depsipeptide   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years ]


  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
No text entered.


  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: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012



Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00104884     History of Changes
Other Study ID Numbers: CDR0000415355
U10CA021115 ( US NIH Grant/Contract Award Number )
E1603 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
Study First Received: March 3, 2005
Results First Received: December 15, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration