RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
Colony-stimulating factors such as sargramostim increase the number of immune cells found in
bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may be
effective in treating soft tissue sarcoma.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with
sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue
- Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim
(GM-CSF) in patients with stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1
or LAGE antigen.
- Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type
hypersensitivity) in patients treated with this regimen.
- Determine tumor responses in patients treated with this regimen.
OUTLINE: Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a
total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) subcutaneously once
daily beginning 2 days before every vaccination and continuing for 5 days. Treatment
continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12 months.
- 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
- 18 and over
- Not specified
- At least 3 months
- Hemoglobin at least 9.0 g/dL
- Lymphocyte count at least 500/mm3
- Platelet count at least 100,000/mm3
- No bleeding disorders
- Bilirubin no greater than 2 mg/dL
- Hepatitis B and C negative
- Creatinine no greater than 1.8 mg/dL
- No New York Heart Association class III or IV heart disease
- 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:
- No prior bone marrow or peripheral blood stem cell transplantation
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No concurrent chemotherapy
- No concurrent steroids except topical or inhaled steroids
- Concurrent noncytotoxic anticancer hormonal therapy allowed (e.g., hormones for
breast or prostate cancer)
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior surgery
- 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