Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial to studying the side effects of vaccine therapy in treating patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Study summary:

OBJECTIVES: - Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer expressing NY-ESO-1 or LAGE-1. - Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients. OUTLINE: This is an open-label study. Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks and then every 6-12 weeks for 2 years or until disease progression. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer - Stage II-IV at diagnosis - Previously treated with cytoreductive surgery and at least 1 platinum-based chemotherapy regimen - High-risk feature, defined as 1 of the following: - Suboptimal primary debulking (remaining tumor masses with diameter at least 1.0 cm) - Failure to normalize CA 125 during primary therapy by the end of the third course - Complete clinical remission, defined as all of the following: - CA 125 less than 35 units - Negative physical examination - No definite evidence of disease by CT scan of the abdomen and pelvis* NOTE: *Lymph nodes and/or soft tissue abnormalities in the pelvis, no greater than 1.0 cm, are not considered definite evidence of disease - HLA-A2 positive - Tumor expression of 1 of the following proteins: - NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis or immunohistochemistry - LAGE-1 by RT-PCR - No more than 4 months since prior primary therapy - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 80,000/mm^3 - No bleeding disorders Hepatic - Bilirubin less than 2.5 times upper limit of normal (ULN) - ALT and AST less than 2.5 times ULN Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No serious infections requiring antibiotics - No serious concurrent illness requiring hospitalization - No other malignancy within the past 3 years except treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No mental impairment that would preclude giving informed consent or complying with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy - Concurrent tamoxifen is allowed - No concurrent systemic corticosteroids Radiotherapy - Not specified Surgery - See Disease Characteristics Other - More than 4 weeks since prior participation in any other investigational study - Concurrent non-cytotoxic anticancer therapy allowed - No concurrent immunosuppressive drugs - No concurrent nonsteroidal anti-inflammatory drugs except as low dose for the prevention of acute cardiovascular events or for pain control


NCT ID:

NCT00066729


Primary Contact:

Study Chair
Jakob Dupont, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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