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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

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Results First Submitted Date  ICMJE June 23, 2021
Results First Posted Date  ICMJE July 14, 2021
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE June 8, 2005
Actual Primary Completion Date April 18, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: up to 10 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
To determine the clinical response of patients with advanced synovial sarcoma following treatment with anti-CTLA4 (RECIST-defined complete response [CR] and partial response [PR]).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
  • Number of Subjects With NY-ESO-1 Specific Immunity as Measured by Antibody Response to NY-ESO-1 or LAGE-1 [ Time Frame: up to 13 weeks ]
    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).
  • Number of Subjects Reporting Adverse Events (AEs) [ Time Frame: up to 13 weeks ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • 1. To determine the clinical benefit rate (CR + PR + stable disease [SD]) of patients with advanced synovial sarcoma following treatment with anti-CTLA4.
  • 2. To evaluate NY-ESO-1 specific immunity (NY-ESO-1 and LAGE-1 antibody, CD8+ and CD4+ T cells, and delayed-type hypersensitivity [DTH]) induced by three doses of anti-CTLA4 antibody in patients with synovial sarcoma.
  • 3. To determine the safety of anti-CTLA4 in patients with synovial sarcoma.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
Official Title  ICMJE A Phase II Study of Anti-CTLA-4 Antibody in Advanced Synovial Sarcoma Patients
Brief Summary The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is effective in people with advanced synovial sarcoma.
Detailed Description

Approximately 750-900 people in the United States each year develop synovial sarcoma, a rare form of cancer of connective tissue. This tumor frequently metastasizes to other parts of the body such as the lungs. Chemotherapy can sometimes decrease the size of the recurrent tumors, but these results are usually only temporary, and the tumors grow again.

We are trying to exploit some of the proteins made by synovial sarcoma (cancer-germ cell or cancer-testis antigens) as targets for the immune system. Specifically, we are investigating if immune-based therapy with anti-CTLA-4 antibody once every 3 weeks for three treatments will activate the immune system enough to attack recurrent synovial sarcoma. In this study the tumor itself serves as the "vaccine" or source of protein, as we try to activate tumor-fighting T cells with the anti-CTLA-4.

Anti-CTLA-4 takes the brakes off the immune system to allow otherwise hidden immune responses to become more active. In so doing, there could be other side effects, such as immune system attacks against the normal organs of the body. We will follow both the anti-tumor immune responses with frequent blood tests and follow and treat side effects people develop on this study to determine if anti-CTLA-4 is worth pursuing in a larger number of patients with synovial sarcoma or other sarcomas.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Synovial Sarcoma
Intervention  ICMJE Biological: ipilimumab
Other Names:
  • Anti-CTLA-4 monoclonal antibody
  • monoclonal antibody MDX-010
  • Yervoy
Study Arms  ICMJE Experimental: ipilimumab
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.
Intervention: Biological: ipilimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 23, 2021)
6
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
17
Actual Study Completion Date  ICMJE July 1, 2007
Actual Primary Completion Date April 18, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented synovial sarcoma.
  • Patients with metastatic disease or locally recurrent disease who have failed or refused standard treatment. The disease must be measurable by RECIST.
  • Expected survival of at least 6 months.
  • Weight at least 35 kg.
  • ECOG performance scale 0-2.
  • At least 3 weeks since major surgery, and at least 3 weeks since completing radiation therapy or chemotherapy (6 weeks for patients receiving mitomycin C).
  • Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before treatment.
  • Adequate bone marrow, renal and hepatic function.
  • Able and willing to give valid written informed consent.

Exclusion Criteria:

  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, e.g. serious infections requiring antibiotics or bleeding disorders.
  • History of autoimmune disease.
  • Serious intercurrent illness, requiring hospitalization.
  • Patients with a second cancer diagnosis in the last five years, except for basal cell carcinoma, completely resected, or cervical carcinoma in situ (CIN), completely resected.
  • Known HIV positivity.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • Chronic use of immunosuppressive drugs such as systemic corticosteroids.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational agent within 3 weeks prior to enrollment.
  • Pregnancy or breast feeding.
  • Refusal or inability to use effective means of contraception (all men, and women with childbearing potential).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140855
Other Study ID Numbers  ICMJE LUD2002-010
MSKCC 04-128 ( Other Identifier: MSKCC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ludwig Institute for Cancer Research
Study Sponsor  ICMJE Ludwig Institute for Cancer Research
Collaborators  ICMJE Medarex
Investigators  ICMJE
Principal Investigator: Robert G Maki, MD PhD Memorial Sloan Kettering Cancer Center
PRS Account Ludwig Institute for Cancer Research
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP