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Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer Clinical research trials and Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare possible for their Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer  Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Corixa Corporation ,
Synopsis: The purpose of this trial is to examine the safety and immunogenicity of a therapeutic prime-boost vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed priming doses of recombinant DNA (pVAX/L523S) followed by two boosting doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.
Details: The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two priming doses of pVAX/L523S and two boosting doses of Ad/L523S. The secondary objectives of the study are: - To provide initial evidence as to whether CD8+ and CD4+ T cell responses specific for L523S protein can be elicited by two priming doses of pVAX/L523S followed by two boosting doses of Ad/L523S - To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two priming doses of pVAX/L523S followed by two boosting doses of Ad/L523S - To investigate the extent to which dose escalation of Ad/L523S affects the elicited immune response
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB non-small cell lung cancer (NSCLC) according to the Revised International System for Staging Lung Cancer - Primary surgical resection of lung cancer greater than or equal to 4 weeks and less than or equal to 52 weeks prior to the Day 0 visit - No evidence of disease by standard diagnostic tests at study entry - Chest X-ray and physical examination showing no active disease - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to 1,500 cells/mm3 - Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than or equal to 150,000 cells/mm3 - Adequate renal function (defined as serum creatinine within normal limits for females and males) - Normal hepatic function (defined as serum bilirubin, AST and alkaline phosphatase within normal limits) - Ability to understand and willingness to sign an IRB-approved written consent prior to study enrollment - Female patients must be greater than or equal to 60 years of age, or greater than or equal to 5 years amenorrhea or surgically sterile - Male patients who are capable of fathering a child and whose partners are capable of having a child must agree to use adequate contraception for 6 months after enrollment (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal ring or IUD) EXCLUSION CRITERIA: - Received pre- or post-operative chemotherapy or radiotherapy - Received prior biologic, immunologic, or gene therapy for cancer - Received an investigational drug (new chemical entity) within three months of study entry - Received antibiotics within 4 weeks of Day 0 visit - Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4 weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing glucocorticosteroids is acceptable) - History of active autoimmune diseases such as, but not limited to, systemic lupus erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or inflammatory bowel disease - History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit - History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens - Received any commercial vaccine within 2 weeks of Day 0 visit - Received a major organ allograft - Current or previous diagnosis of paraneoplastic syndrome - Evidence of a clinically significant active infection, emphysema, FeV1 less than or equal to 60% predicted, DLCO less than or equal to 60% predicted, pulse oximetry less than or equal to 92% at the time of study entry - Known to be HIV positive - Results of virology screening indicate positive serology for HCV (hepatitis C virus) and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is allowed. - History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured - Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment - Patient is lactating - Staging classification of TX or NX or MX
Total Enrollment: 9
Location and Contact Information:
US Oncology *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Rob Eager 214-370-1820
Additional Information:
Study ID Numbers: CCL5001-01;
Study Start Date: May 2003
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062907
Other Non-Small Cell Lung Cancer Studies:
1. Subcutaneous Amifostine (Ethyol®) In The Prevention Of Radiochemotherapy-Induced Esophagitis And Pneumonitis In Patients With Unresectable Non-Small Cell Lung Cancer
2. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
3. Iressa/Docetaxel in Non-Small-Cell Lung Cancer
4. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
5. INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
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