Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, stage II adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-risk stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen (including, but not limited to, synovial sarcoma) HLA-A2 allele for NY-ESO-1 peptides Declined, failed, or completed standard therapy CNS metastases allowed if treated and stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL Lymphocyte count at least 500/mm3 Platelet count at least 100,000/mm3 No bleeding disorders Hepatic: Bilirubin no greater than 2 mg/dL Hepatitis B and C negative Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other serious illness (e.g., serious infection requiring antibiotics) No immunodeficiency disease No psychiatric or addictive disorders that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem cell transplantation At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: No concurrent steroids except topical or inhaled steroids Concurrent noncytotoxic anticancer hormonal therapy allowed (e.g., hormones for breast or prostate cancer) Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery Other: At least 4 weeks since prior participation in any other clinical trial involving another investigational agent No concurrent antihistamines No concurrent non-steroidal anti-inflammatory drugs except low doses for prevention of an acute cardiovascular event or pain control No concurrent immunosuppressive agents Concurrent noncytotoxic anticancer therapy allowed
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University