Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI CPMC-IRB-13578 LUDWIG-LUD00-024, NCI-G01-2035, NCT00027911

Objectives

1. 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.
2. Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) in patients treated with this regimen.
3. Determine tumor responses in patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

A total of 15 patients will be accrued for this study within 12 months.

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Kyriakos Papadopoulos, MD, Protocol chair(Contact information may not be current)		Ph: 212-305-9327

Registry Information
Official Title		A Pilot Study of NY-ESO-1 Immunization in Patients with NY-ESO-1/LAGE Antigen Expressing Cancer
Trial Start Date		2001-04-02
Registered in ClinicalTrials.gov		NCT00027911
Date Submitted to PDQ		2001-10-24
Information Last Verified		2004-04-08
NCI Grant/Contract Number		P30-CA13696