A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma (NCT00140855) | Clinical Trial Compass
TerminatedPhase 2
A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
Stopped: Study discontinued due to poor accrual.
United States6 participantsStarted 2005-06-08
Plain-language summary
The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is effective in people with advanced synovial sarcoma.
Who can participate
Age range10 Years
SexALL
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Inclusion Criteria:
* Histologically documented synovial sarcoma.
* Patients with metastatic disease or locally recurrent disease who have failed or refused standard treatment. The disease must be measurable by RECIST.
* Expected survival of at least 6 months.
* Weight at least 35 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 C).
* Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before treatment.
* Adequate bone marrow, renal and hepatic function.
* 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.
* Serious intercurrent illness, requiring hospitalization.
* 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 availa…
What they're measuring
1
Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).