A Study of Anti-CTLA4 Antibody in People With Advanced Synovial Sarcoma
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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 |
- 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]).
- 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 |
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 |
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| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| 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 Cytotoxic T-lymphocyte antigen 4 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 23, 2013