Status:
TERMINATED
A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Medarex
Conditions:
Synovial Sarcoma
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00140855
Start Date
June 8 2005
End Date
July 1 2007
Last Update
October 12 2022
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021