Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

This study has been terminated.
(Departure of PI)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00027911
First received: December 7, 2001
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Sarcoma
Biological: NY-ESO-1 peptide vaccine
Biological: sargramostim
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Study Start Date: April 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027911

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Study Chair: Kyriakos P. Papadopoulos, MD Herbert Irving Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00027911     History of Changes
Other Study ID Numbers: AAAB2273, CPMC-IRB-13578, LUDWIG-LUD00-024, NCI-G01-2035
Study First Received: December 7, 2001
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on October 28, 2014