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

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. 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
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

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.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Biological: ipilimumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-CTLA-4 Antibody in Advanced Synovial Sarcoma Patients
Actual Study Start Date : June 8, 2005
Actual Primary Completion Date : April 18, 2007
Actual Study Completion Date : July 1, 2007

Arm Intervention/treatment
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.
Biological: ipilimumab
Other Names:
  • Anti-CTLA-4 monoclonal antibody
  • monoclonal antibody MDX-010
  • Yervoy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140855

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
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Principal Investigator: Robert G Maki, MD PhD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Ludwig Institute for Cancer Research Identifier: NCT00140855    
Other Study ID Numbers: LUD2002-010
MSKCC 04-128 ( Other Identifier: MSKCC )
First Posted: September 1, 2005    Key Record Dates
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ludwig Institute for Cancer Research:
synovial sarcoma
cancer-testis antigen
cancer-germ cell antigen
soft tissue sarcoma
SYT-SSX chromosomal translocation
Additional relevant MeSH terms:
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Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Antineoplastic Agents, Immunological
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents