Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

NCT00027911 | Terminated Phase 1

• 4 other identifiers: AAAB2273CPMC-IRB-13578LUDWIG-LUD00-024NCI-G01-2035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

NY-ESO-1 peptide vaccine BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sarcoma; Sarcoma, Synovial

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue

Study Officials

• Kyriakos P. Papadopoulos, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)