Working… Menu

A Study of Anti-CTLA4 Antibody in People 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
Last Update Posted : March 9, 2018
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:
The purpose of this study is to determine whether immune therapy with anti-CTLA4 antibody is effective in people with advanced synovial sarcoma.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Drug: Anti-CTLA4 (monoclonal antibody MDX-010) 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-CTLA4 antibody once every 4 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-CTLA4.

Anti-CTLA4 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-CTLA4 is worth pursuing in a larger number of patients with synovial sarcoma or other sarcomas.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients
Study Start Date : July 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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]).

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically documented synovial sarcoma
  • RECIST measurable metastatic or locally recurrent disease who have failed standard treatment
  • Expected survival of at least 6 months
  • Weight at least 25 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)
  • Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before treatment
  • Adequate bone marrow, renal and hepatic function
  • Age at least 13 years
  • 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
  • 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

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Layout table for investigator information
Principal Investigator: Robert G Maki, MD PhD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information Identifier: NCT00140855    
Other Study ID Numbers: LUD2002-010
MSKCC 04-128
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
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:
Layout table for MeSH terms
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents