Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
ClinicalTrials.gov Identifier: NCT00140855
Recruitment Status : Terminated (Study discontinued due to poor accrual.)
First Posted : September 1, 2005
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Medarex
Information provided by:
Ludwig Institute for Cancer Research

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date March 9, 2018
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current 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]).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2006)
  • To determine the clinical benefit rate (CR + PR + stable disease [SD]) of patients with advanced synovial sarcoma following treatment with anti-CTLA4.
  • 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.
  • To determine the safety of anti-CTLA4 in patients with synovial sarcoma.
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-CTLA4 Antibody in People With Advanced Synovial Sarcoma
Official Title  ICMJE A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Synovial Sarcoma
Intervention  ICMJE Drug: Anti-CTLA4 (monoclonal antibody MDX-010)
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: August 30, 2005)
17
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 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
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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 March 2018

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