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Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112463
First Posted: June 3, 2005
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: April 4, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Rhabdomyosarcoma
Adult Synovial Sarcoma
Gastrointestinal Stromal Tumor
Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Adult Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Intervention: Drug: romidepsin

  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
Treatment (Single-agent Depsipeptide) Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

Participant Flow:   Overall Study
    Treatment (Single-agent Depsipeptide)
STARTED   40 
COMPLETED   1 
NOT COMPLETED   39 
Physician Decision                1 
Progression                30 
Second Primary                1 
Toxicity                3 
Withdrawal by Subject                2 
Never started treatment                2 



  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 registered participants

Reporting Groups
  Description
Treatment (Single-agent Depsipeptide) Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

Baseline Measures
   Treatment (Single-agent Depsipeptide) 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      24  60.0% 
>=65 years      16  40.0% 
Age 
[Units: Years]
Median (Full Range)
 59 
 (19 to 88) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  47.5% 
Male      21  52.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      40 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5  12.5% 
White      32  80.0% 
More than one race      0   0.0% 
Unknown or Not Reported      2   5.0% 
Region of Enrollment 
[Units: Participants]
 
United States   40 


  Outcome Measures
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1.  Primary:   Objective Tumor Response (Complete and Partial)   [ Time Frame: While on treatment - max of 16 months ]

2.  Primary:   Time to Progression   [ Time Frame: Until disease progression - max of 48 months ]

3.  Primary:   Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3   [ Time Frame: During treatment (max of 16 months) and for 1 month following treatment ]

4.  Secondary:   Survival   [ Time Frame: Max of 98 months ]


  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: Dr. Doug Case
Organization: Wake Forest School of Medicine
phone: 336-716-1048
e-mail: dcase@wakehealth.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112463     History of Changes
Obsolete Identifiers: NCT01645683
Other Study ID Numbers: NCI-2012-01037
NCI-2012-01037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 71103 ( Other Identifier: Wake Forest University Health Sciences )
6319 ( Registry Identifier: CTEP )
U10CA081851 ( U.S. NIH Grant/Contract )
P30CA012197 ( U.S. NIH Grant/Contract )
First Submitted: June 2, 2005
First Posted: June 3, 2005
Results First Submitted: April 4, 2017
Results First Posted: May 12, 2017
Last Update Posted: June 14, 2017