Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027911
Recruitment Status : Terminated (Departure of PI)
First Posted : January 27, 2003
Last Update Posted : February 15, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Columbia University

Brief Summary:

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 or disease Intervention/treatment Phase
Sarcoma Biological: NY-ESO-1 peptide vaccine Biological: sargramostim Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer
Study Start Date : April 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Performance status:

  • Not specified

Life expectancy:

  • 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


Biologic 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

Endocrine therapy:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027911

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Cancer Institute (NCI)
Study Chair: Kyriakos P. Papadopoulos, MD Herbert Irving Comprehensive Cancer Center

Responsible Party: Columbia University Identifier: NCT00027911     History of Changes
Other Study ID Numbers: AAAB2273
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Columbia University:
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

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs