A Study of Anti-CTLA4 Antibody in People With Advanced Synovial Sarcoma

This study has been terminated.
(Study discontinued due to poor accrual.)
Sponsor:
Collaborator:
Medarex
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00140855
First received: August 30, 2005
Last updated: April 4, 2007
Last verified: April 2007

August 30, 2005
April 4, 2007
July 2005
Not Provided
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]).
Same as current
Complete list of historical versions of study NCT00140855 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
A Study of Anti-CTLA4 Antibody in People With Advanced Synovial Sarcoma
A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Synovial Sarcoma
Drug: Anti-CTLA4 (monoclonal antibody MDX-010)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
April 2007
Not Provided

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)
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140855
LUD2002-010, MSKCC 04-128
Yes
Not Provided
Ludwig Institute for Cancer Research
Medarex
Principal Investigator: Robert G Maki, MD PhD Memorial Sloan-Kettering Cancer Center
Ludwig Institute for Cancer Research
April 2007

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