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Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
Official Title  A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer
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.

Detailed Description

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 Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Sarcoma
Intervention  Drug: NY-ESO-1 peptide vaccine
Drug: sargramostim
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  April 2001
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00027911
Organization ID CDR0000069092
Secondary IDs †† CPMC-IRB-13578, LUDWIG-LUD00-024, NCI-G01-2035
Study Sponsor  Herbert Irving Comprehensive Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Kyriakos P. Papadopoulos, MD     Herbert Irving Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2004
First Received Date  December 7, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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