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Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NY-ESO-1 peptide vaccine
sargramostim
Sponsored by
Columbia University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
February 13, 2013
Sponsor
Columbia University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027911
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Departure of PI
Study Start Date
April 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
NY-ESO-1 peptide vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos P. Papadopoulos, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

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