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
  Purpose

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


Condition Intervention Phase
Synovial Sarcoma
Drug: Anti-CTLA4 (monoclonal antibody MDX-010)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-CTLA4 Antibody in Advanced Synovial Sarcoma Patients

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 17
Study Start Date: July 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140855

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Medarex
Investigators
Principal Investigator: Robert G Maki, MD PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00140855     History of Changes
Other Study ID Numbers: LUD2002-010, MSKCC 04-128
Study First Received: August 30, 2005
Last Updated: April 4, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
synovial sarcoma
immunotherapy
cancer-testis antigen
cancer-germ cell antigen
soft tissue sarcoma
SYT-SSX chromosomal translocation

Additional relevant MeSH terms:
Sarcoma, Synovial
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014