Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer.


Study summary:

OBJECTIVES: Primary - Determine the remission rate in patients with NY-ESO-1 or LAGE-1 expressing stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer who are still in complete clinical remission 12 months after initial documentation of remission treated with vaccine therapy comprising vaccinia-NY-ESO-1 vaccine and fowlpox-NY-ESO-1 vaccine. Secondary - Determine the NY-ESO-1 specific cellular and humoral immunity, by evaluating NY-ESO-1 specific antibody and CD8+ T cells induced by this regimen, in these patients. - Correlate time to treatment failure with vaccine-induced NY-ESO-1 antigen specific cellular or humoral immunity in these patients. - Determine the safety of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive vaccinia-NY-ESO-1 vaccine intradermally on day 1 and fowlpox-NY-ESO-1 vaccine subcutaneously on days 29, 57, 85, 113, 141, and 169 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 14-36 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer - Stage II-IV disease at diagnosis - Tumor expression of 1 of the following: - NY-ESO-1 by reverse transcription polymerase chain reaction (RT-PCR) analysis OR immunohistochemistry - LAGE-1 by RT-PCR - Demonstrated complete response to prior first-line initial surgery and chemotherapy, as evidenced by negative clinical examination, CA 125 tumor marker, and CT scan - No evidence of microscopic or macroscopic disease by second look surgery (if performed) - Received ≥ 1 platinum-based chemotherapy regimen within the past 6 months - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 6 months Hematopoietic - Neutrophil count ≥ 1,500/mm^3 - Lymphocyte count ≥ 500/mm^3 - Platelet count ≥ 100,000/mm^3 - No bleeding disorder Hepatic - Bilirubin ≤ 2 mg/dL Renal - Creatinine ≤ 2 mg/dL Cardiovascular - No myocardial infarction - No angina - No congestive heart failure - No cardiomyopathy - No stroke or transient ischemic attack - No chest pain or shortness of breath with activity - No other heart condition being treated by a doctor - No presence of ≥ 3 of the following cardiac risk factors: - Hypertension - Hypercholesterolemia - Diabetes - Has a first-degree relative (e.g., mother, father, brother, or sister) who had a heart condition at < 50 years of age - Current cigarette smoker Immunologic - No known allergy or severe reaction to a vaccinia (small pox) vaccination - No known history of allergy to eggs - No known HIV positivity - No history of autoimmune disease (e.g., thyroiditis or lupus) - No prior or current eczema or atopic dermatitis - None of the following acute, chronic, or exfoliative skin conditions: - Burns - Chicken pox - Shingles - Impetigo - Herpes - Severe acne - Psoriasis - No serious infection requiring antibiotics Other - No other serious illness - No mental impairment that would preclude giving informed consent or study compliance - Able to avoid close contact with any of the following individuals while receiving the study therapy: - Children < 3 years of age - Pregnant or nursing women - Individuals with prior or active eczema or atopic dermatitis - Individuals with other prior or active skin disorders, including any of the following: - Burns - Chicken pox - Shingles - Impetigo - Herpes - Severe acne - Psoriasis - Immunocompromised individuals, including those with any of the following conditions: - HIV - Leukemia - Lymphoma - Solid organ transplantation - Generalized malignancy - Cellular or humoral immunodeficiency syndromes - Currently receiving cytotoxic chemotherapy, radiotherapy, or high-dose corticosteroids PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy - No concurrent systemic corticosteroids - Concurrent hormonal therapy for breast cancer allowed - Concurrent tamoxifen therapy for ovarian cancer allowed Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - See Disease Characteristics - Recovered from prior surgery Other - More than 4 weeks since prior participation in a clinical trial involving another investigational agent - No concurrent systemic antihistamines - No concurrent systemic nonsteroidal anti-inflammatory drugs - No other concurrent immunosuppressive agents - Concurrent noncytotoxic anticancer therapy allowed


NCT ID:

NCT00112957


Primary Contact:

Principal Investigator
Adekunle O. Odunsi, MD, PhD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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