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A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kyriakos P. Papadopoulos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

AAAB2273

NCT ID:

NCT00027911

Start Date:

April 2001

Completion Date:

June 2005

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032