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A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma

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ClinicalTrials.gov Identifier: NCT00140855
Recruitment Status : Terminated (Study discontinued due to poor accrual.)
First Posted : September 1, 2005
Results First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Synovial Sarcoma
Intervention Biological: ipilimumab
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipilimumab
Hide Arm/Group Description Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Reason Not Completed
Progressive disease             2
Arm/Group Title Ipilimumab
Hide Arm/Group Description Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
All subjects who entered the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
Hide Description Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
Time Frame up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who entered the study.
Arm/Group Title Ipilimumab
Hide Arm/Group Description:
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
CR
0
   0.0%
PR
0
   0.0%
SD
0
   0.0%
PD
6
 100.0%
2.Secondary Outcome
Title Number of Subjects With NY-ESO-1 Specific Immunity as Measured by Antibody Response to NY-ESO-1 or LAGE-1
Hide Description Blood samples were taken at baseline and weeks 4, 7, 10 and 13. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 or LAGE by enzyme-linked immunosorbent assay (ELISA). Positive results are reported as antibodies to NY-ESO-1- and/or LAGE-1-specific Total IgG (reciprocal titer).
Time Frame up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who entered the study.
Arm/Group Title Ipilimumab
Hide Arm/Group Description:
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Number of subjects with positive antibody titers
0
   0.0%
Number of patients with negative antibody titers
6
 100.0%
3.Secondary Outcome
Title Number of Subjects Reporting Adverse Events (AEs)
Hide Description All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
Time Frame up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who entered the study.
Arm/Group Title Ipilimumab
Hide Arm/Group Description:
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
Time Frame up to 13 weeks
Adverse Event Reporting Description All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
 
Arm/Group Title Ipilimumab
Hide Arm/Group Description Three doses of ipilimumab 3 mg/kg, were administered by intravenous infusion at 3 week intervals. A 6-week observation period followed the final dose.
All-Cause Mortality
Ipilimumab
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Serious Adverse Events
Ipilimumab
Affected / at Risk (%)
Total   2/6 (33.33%) 
Gastrointestinal disorders   
Diarrhea  1  1/6 (16.67%) 
Vomiting  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 7.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ipilimumab
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Lymphopenia  1  2/6 (33.33%) 
Endocrine disorders   
Hyperglycemia  1  1/6 (16.67%) 
Gastrointestinal disorders   
Diarrhea  1  1/6 (16.67%) 
Proctalgia  1  1/6 (16.67%) 
Gastritis  1  1/6 (16.67%) 
Abdominal pain  1  1/6 (16.67%) 
General disorders   
Fatigue  1  1/6 (16.67%) 
Hepatobiliary disorders   
Hyperbilirubinemia  1  3/6 (50.00%) 
Infections and infestations   
Bronchitis  1  1/6 (16.67%) 
Investigations   
Blood alkaline phosphatase  1  3/6 (50.00%) 
Alanine aminotransferase  1  1/6 (16.67%) 
Platelet count  1  2/6 (33.33%) 
Hemoglobin  1  1/6 (16.67%) 
White blood count  1  1/6 (16.67%) 
Blood creatinine  1  1/6 (16.67%) 
Aspartate aminotransferase  1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Hypophosphatemia  1  1/6 (16.67%) 
Hypocalcemia  1  1/6 (16.67%) 
Hypoalbuminemia  1  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/6 (16.67%) 
Musculoskeletal chest pain  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Chest pain  1  2/6 (33.33%) 
Pleural effusion  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Exfoliative rash  1  1/6 (16.67%) 
Dermatitis acneform  1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 7.0
Indicates events were collected by systematic assessment
This study was terminated early due to slow recruitment.
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
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Senior Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: 12124501546
EMail: mmacri@lcr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00140855    
Other Study ID Numbers: LUD2002-010
MSKCC 04-128 ( Other Identifier: MSKCC )
First Submitted: August 30, 2005
First Posted: September 1, 2005
Results First Submitted: June 23, 2021
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021