Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

Phase 1TerminatedNCT00027911

Columbia University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Sarcoma

Interventions

NY-ESO-1 peptide vaccineBIOLOGICAL

sargramostimBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Data from ClinicalTrials.gov

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