Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

Sponsor

Columbia University (Other)

Overall Status

Terminated

CT.gov ID

NCT00027911

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

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

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 Design

Study Type:

Interventional

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 :

Apr 1, 2001

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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