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 sarcoma.

Condition	Treatment or Intervention	Phase
adult soft tissue sarcoma adult synovial sarcoma	Drug: NY-ESO-1 peptide vaccine  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I

Further Study Details: 

OBJECTIVES:

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States

Study chairs or principal investigators

Kyriakos P. Papadopoulos, MD,  Study Chair,  Columbia Presbyterian Medical Center   

Study ID Numbers:  CDR0000069092; CPMC-IRB-13578; LUDWIG-LUD00-024; NCI-G01-2035
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027911
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08