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Trial record 17 of 66 for:    Sarcoma | "Dermatofibroma"

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

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ClinicalTrials.gov Identifier: NCT00112463
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : May 12, 2017
Last Update Posted : June 14, 2017
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 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
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 40
Completed 1
Not Completed 39
Reason Not Completed
Physician Decision             1
Progression             30
Second Primary             1
Toxicity             3
Withdrawal by Subject             2
Never started treatment             2
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
All registered participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  60.0%
>=65 years
16
  40.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
59
(19 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
19
  47.5%
Male
21
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Objective Tumor Response (Complete and Partial)
Hide Description Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
Time Frame While on treatment - max of 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluable for response
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.7%
2.Primary Outcome
Title Time to Progression
Hide Description Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.
Time Frame Until disease progression - max of 48 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.7 to 2.5)
3.Primary Outcome
Title Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
Hide Description

The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.

A summary of the individual toxicities can be found in the AE/SAE results.

Time Frame During treatment (max of 16 months) and for 1 month following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description:

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.

romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
13
  34.2%
4.Secondary Outcome
Title Survival
Hide Description Months from first treatment until death or the last date of contact
Time Frame Max of 98 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
12.2
(7.6 to 19.3)
Time Frame During treatment (max of 16 months) and for 1 month following treatment
Adverse Event Reporting Description Toxicities were evaluated weekly while the participant was on treatment
 
Arm/Group Title Treatment (Single-agent Depsipeptide)
Hide Arm/Group Description 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.
All-Cause Mortality
Treatment (Single-agent Depsipeptide)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Single-agent Depsipeptide)
Affected / at Risk (%) # Events
Total   13/38 (34.21%)    
Blood and lymphatic system disorders   
Coagulation - Other  1  1/38 (2.63%)  1
Cardiac disorders   
Cardiac Arrhythmia - Other  1  3/38 (7.89%)  4
Cardiac Dysrhythmia  1  1/38 (2.63%)  1
Cardiac General - Other  1  2/38 (5.26%)  2
Endocrine disorders   
Hyperglycemia  1  2/38 (5.26%)  3
Gastrointestinal disorders   
Constipation  1  2/38 (5.26%)  2
GI - Other  1  1/38 (2.63%)  1
Nausea  1  3/38 (7.89%)  5
Vomiting  1  4/38 (10.53%)  5
Infections and infestations   
Infection - Other  1  1/38 (2.63%)  1
Metabolism and nutrition disorders   
Anorexia  1  2/38 (5.26%)  2
Dehydration  1  3/38 (7.89%)  4
Malise/Fatigue  1  1/38 (2.63%)  1
Metabolic - Other  1  3/38 (7.89%)  4
Weight Loss  1  1/38 (2.63%)  1
Nervous system disorders   
Pain - Other  1  1/38 (2.63%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Single-agent Depsipeptide)
Affected / at Risk (%) # Events
Total   38/38 (100.00%)    
Blood and lymphatic system disorders   
Coagulation - Other  1  3/38 (7.89%)  5
Hemoglobin  1  11/38 (28.95%)  84
Cardiac disorders   
Cardiac Arrhythmia  1  5/38 (13.16%)  9
Caridac General - Other  1  4/38 (10.53%)  4
Endocrine disorders   
Hot flashes/flushes  1  3/38 (7.89%)  19
Hyperglycemia  1  5/38 (13.16%)  14
Gastrointestinal disorders   
Constipation  1  19/38 (50.00%)  82
Constitutional Symptioms - Other  1  13/38 (34.21%)  51
Diarrhea  1  8/38 (21.05%)  9
Dyspepsia/Heartburn  1  4/38 (10.53%)  20
GI - Other  1  25/38 (65.79%)  65
Nausea  1  26/38 (68.42%)  150
Vomiting  1  15/38 (39.47%)  42
Immune system disorders   
AGC/ANC  1  3/38 (7.89%)  5
Infections and infestations   
Fever in the absence of neutropenia  1  3/38 (7.89%)  4
Infection - Other  1  6/38 (15.79%)  10
Mucositis/stomatitis  1  4/38 (10.53%)  6
WBC  1  4/38 (10.53%)  11
Metabolism and nutrition disorders   
Anorexia  1  9/38 (23.68%)  55
Malise/Fatigue  1  32/38 (84.21%)  198
Metabolic - Other  1  9/38 (23.68%)  21
Weight Gain  1  3/38 (7.89%)  3
Weight Loss  1  11/38 (28.95%)  18
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  5/38 (13.16%)  8
Musculoskeletal/Soft Tissue - Other  1  11/38 (28.95%)  23
Nervous system disorders   
Dizziness  1  3/38 (7.89%)  16
Neurologic - Other  1  14/38 (36.84%)  59
Pain - Other  1  22/38 (57.89%)  123
Pain: Abdomen NOS  1  3/38 (7.89%)  8
Pain: Back  1  4/38 (10.53%)  5
Pain: Extremity-limb  1  4/38 (10.53%)  15
Pain: Head/Headache  1  4/38 (10.53%)  5
Pain: NOS  1  7/38 (18.42%)  22
Taste Alteration  1  7/38 (18.42%)  49
Renal and urinary disorders   
Creatinine  1  3/38 (7.89%)  3
Renal/Genitourinary - Other  1  5/38 (13.16%)  7
Respiratory, thoracic and mediastinal disorders   
Dyspnea/SOB  1  14/38 (36.84%)  26
Pulmonary Other  1  7/38 (18.42%)  18
Skin and subcutaneous tissue disorders   
Dermatology/Skin  1  6/38 (15.79%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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. Doug Case
Organization: Wake Forest School of Medicine
Phone: 336-716-1048
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