Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how well it works compared to observation in treating patients with nasopharyngeal cancer at high risk for recurrence after standard therapy.


Study summary:

OBJECTIVES: Primary - Determine the efficacy of adjuvant vaccine therapy comprising either Epstein-Barr virus (EBV)-encoded latent membrane protein (LMP)-2: 340-349 peptide or EBV -encoded LMP-2: 419-427 peptide emulsified in Montanide ISA-51, in terms of inducing CD8+ T-cell responses, in patients with anaplastic nasopharyngeal carcinoma at high risk for recurrence. Secondary - Determine the safety of these regimens in these patients. - Determine whether plasma anti-EBV titers parallel the natural history or treatment-induced history of this disease in these patients. - Determine whether plasma anti-EBV titers can be used as surrogate markers to monitor the efficacy of these regimens in these patients. OUTLINE: Patients are assigned to 1 of 3 treatment groups according to HLA typing. - Group 1 (HLA-A*1101): Patients receive Epstein-Barr virus (EBV)-encoded latent membrane protein (LMP)-2: 340-349 peptide emulsified in Montanide ISA-51 subcutaneously (SC) once weekly in weeks 1-8. - Group 2 (HLA-A*2402)*: Patients receive EBV-encoded LMP-2: 419-427 peptide emulsified in Montanide ISA-51 SC once weekly in weeks 1-8. - Group 3 (non HLA-A*1101 and non HLA-A*2402): Patients undergo observation only for at least 12 weeks. NOTE: *Patients who express both HLA-A*1101 and HLA-A*2402 are assigned to group 2. In groups 1 and 2, treatment repeats every 12 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, immune response is assessed. Patients with no immune response undergo observation. Patients with an objective immune response may receive 2 additional courses of therapy for a maximum of 4 courses (approximately 1 year). After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years. PROJECTED ACCRUAL: A total of 42-99 patients (14-33 per treatment group) will be accrued for this study within 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed anaplastic nasopharyngeal carcinoma (NPC), meeting 1 of the following criteria at disease onset: - Advanced local disease (T3-T4, N0-N1, M0) - Nodal disease (T1-T2, N2-N3, M0) - Locoregional disease (T3-T4, N2-N3, M0) - Completely resected metastatic disease - Disease free by physical examination; ear, nose, and throat endoscopy; CT scan of abdomen, chest, neck, and nasal sinuses; and MRI of the head performed within the past 6 weeks - Disease controlled by standard surgery OR standard chemotherapy and radiotherapy - Completed standard therapy ≥ 3 months before study entry - Demonstrates evidence of local control with no histological or radiological evidence of recurrent disease - HLA-A*1101- or HLA-A*2042-positive disease* by high resolution molecular testing NOTE: *Patients who do not meet the above HLA typing criteria are assigned to the study observation group PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,000/mm^3 - Platelet count ≥ 90,000/mm^3 Hepatic - AST and ALT < 3 times normal - Bilirubin ≤ 1.6 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome) - Hepatitis B surface antigen negative - Hepatitis C positivity allowed provided patients meet the above AST and ALT criteria Renal - Creatinine ≤ 2.0 mg/dL Immunologic - HIV negative - No known hypersensitivity to study agents - No known immunodeficiency disease - No active primary or secondary immunodeficiency - No autoimmune disease - No active systemic infection Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 month since prior systemic biologic therapy in the adjuvant or metastatic setting Chemotherapy - See Disease Characteristics - At least 1 month since prior systemic chemotherapy in the adjuvant or metastatic setting Endocrine therapy - No concurrent systemic steroid therapy Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics - At least 1 month since prior surgery for NPC Other - Recovered from all prior therapy (alopecia allowed) - At least 1 month since other prior systemic therapy in the adjuvant or metastatic setting - More than 3 weeks since prior systemic therapy for NPC - No other concurrent systemic therapy for NPC


NCT ID:

NCT00112541


Primary Contact:

Principal Investigator
Francesco M. Marincola, MD
NIH - Warren Grant Magnuson Clinical Center


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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