Clinical trial · Interventional
A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
A Phase II Study of Anti-CTLA-4 Antibody in Advanced Synovial Sarcoma Patients
NCT00140855CI-TRIAL-00061388terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study discontinued due to poor accrual.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is effective in people with advanced synovial sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Synovial Sarcoma | Synovial Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ipilimumab
- description
- Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
- interventionNames
- Biological: ipilimumab
Primary outcomes (1)
- measure
- Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
- timeFrame
- up to 10 weeks
- description
- Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
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 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).
References
Publications (2)
- BACKGROUNDTherasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. PMID 10655437
- RESULTMaki RG, Jungbluth AA, Gnjatic S, Schwartz GK, D'Adamo DR, Keohan ML, Wagner MJ, Scheu K, Chiu R, Ritter E, Kachel J, Lowy I, Old LJ, Ritter G. A Pilot Study of Anti-CTLA4 Antibody Ipilimumab in Patients with Synovial Sarcoma. Sarcoma. 2013;2013:168145. doi: 10.1155/2013/168145. Epub 2013 Feb 27. PMID 23554566