A Study of Anti-CTLA4 Antibody in People With Advanced Synovial Sarcoma

• Status: Terminated
• Trial end date: 0000-00-00
• Target enrollment: 17
• Participant gender: Both

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborator: Medarex
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins
• Last Updated: 2007-04-04

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)