Finding studies
Finding studies
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Lead
NewLink Genetics Corporation
With
Background: * Lung cancer remains the leading cause of cancer death with an estimated 174,400 new cases and 162,400 deaths each year in the U.S. * Despite attempts at early diagnosis and the development of new therapeutic agents, there has been only limited improvement in the outcome for patients with advanced lung cancer. * A enzyme called alpha(1,3)galactosyltranferase (alphaGT) that is not found in humans can transfer sugars on to proteins in human cells that can make them highly immunogenic and cause them to be rejected by the body. * Antitumor vaccination using killed donor human lung cancer cells expressing alphaGT may stimulate immune responses in patients against their own lung cancer because their lung cancer may share antigens with the vaccine cells that have been made more immunogenic by expression of alphaGT. Objectives: Phase I has been completed. Phase II * To assess the tumor response rate of anti-tumor vaccination using irradiated allogeneic lung cancer cell lines genetically engineered to express the murine alpha(1,3)galactosyltransferase enzyme in patients with advanced, recurrent or refractory non-small cell lung cancer. * To assess the immunological response of patients with lung cancer undergoing antitumor vaccination with irradiated allogeneic lung cancer cell lines genetically engineered to express murine alpha(1,3)galactosyltransferase. * Assess the survival distribution as well as the duration of response. Eligibility: * Non-small cell lung cancer (Adenocarcinoma, squamous cell carcinoma, large cell anaplastic carcinoma and bronchoalveolar carcinoma). * Stage IV, recurrent or treatment refractory disease. * No exclusion for prior therapy. Prior therapy may include surgery, radiation, immunotherapy, and chemotherapy regimens. EGFR inhibitors or monoclonal antibodies are included as chemotherapy. * Patients must have a granulocyte count of greater than or equal to 1000/microL, platelets greater than or equal to 100,000/microL, hemoglobin greater than 10.0 gm/dL, albumin greater than or equal to 3.0 gm/dL and acceptable hepatic and renal function. * No systemic corticosteroids. Design (Phase II): * Patients will be intradermally vaccinated with 300 million alpha(1,3)galactosyltranferase-expressing vaccine cells every 2-weeks to complete a total of eight vaccinations. * Patients will be monitored for tumor and immunological responses and safety.
Age
21–65
Sex
ALL
Healthy volunteers
Not accepted
