Peptide Vaccine to Prevent Recurrence of Nasopharyngeal Cancer
This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2 protein may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide.
Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by standard treatment with surgery, chemotherapy, or radiation therapy and who are currently free of disease may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests. x-rays and other imaging studies are also done in patients who have not had these tests recently. All candidates are tested for HLA tissue type. Only patients with type HLA-A*1101 or HLA-A*2402 - the types on which the two vaccines in this study are based - receive vaccine therapy; others are offered standard medical treatment and observation.
Participants are randomly assigned to receive injections of one of two different vaccines (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are given under the skin of the thigh. After every other treatment course (about every 3 months), patients undergo a series of x-rays and scans to look for tumor. The immunizations are given at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects. Immunizations may continue for up to 12 months as long as the cancer does not return.
Patients are followed with blood tests every 12 weeks to monitor body functions. They also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood is processed by a machine that separates and removes the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the vaccine's effects on the tumor immune cells.
Patients who show no evidence of immunization against the LMP-2 protein after two courses of vaccine treatment are subsequently be followed with observation alone. Those who do respond to the vaccine are offered two additional courses of treatment to strengthen the response or to be followed by observation alone. Patients whose disease recurs after completing the first two treatment courses are taken off the study and referred back to their local physician or to another study, if an appropriate one is available.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Latent Membrane Protein (LMP) - 2 Immunization for the Assessment of the Natural History and the Immunization-Induced Immunological Response in Patients at High Risk for Recurrence of Anaplastic Nasopharyngeal Cancer|
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||May 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078494
|United States, Maryland|
|National Institutes of Health Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|