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Vaccine Treatment for Advanced Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Vaccine Treatment for Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer Clinical research trials and Vaccine Treatment for Advanced Non-Small Cell Lung Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Vaccine Treatment for Advanced Non-Small Cell Lung Cancer. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Vaccine Treatment for Advanced Non-Small Cell Lung Cancer clinical trial. Subjects frequently get the best healthcare possible for their Vaccine Treatment for Advanced Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Treatment for Advanced Non-Small Cell Lung Cancer  Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
For Condition: Carcinoma, Non-Small-Cell Lung
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This 2-phase study will determine the safety of treating patients with non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed lung cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink. Patients 18 years of age or older with non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, urinalysis, chest x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be obtained if needed. Participants will receive four vaccinations a month apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects: - Medical history and physical examination - Blood tests - X-rays and various scans (nuclear medicine/CT/MRI) - FACT-L Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, before each vaccination, and during follow-up visits after completing the treatment. It includes questions on the severity of lung cancer symptoms and the ability to perform normal activities of daily life. In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination site to look for a local immune response. For this procedure, an area of skin is numbed with an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie cutter-type instrument. Also, one blood sample per year will be collected for the next 15 years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy of the lesion to see what effect the treatment may be having on the tumor.
Details: According to statistics of the American Cancer Society, an estimated 169,400 individuals will be diagnosed with lung cancer and 154,900 will die of the disease this year despite all current therapy. This protocol attempts to exploit an approach to lung cancer gene therapy using a naturally occurring barrier to xenotransplantation in humans in attempt to vaccinate patients against their lung cancer. The expression of the murine alpha (1,3) galactosyltransferase [alpha (1,3) GT] gene results in the cell surface expression of alpha (1,3) galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man. Human hosts often have pre-existing anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora leading to chronic immunological stimulation. These antibodies may comprise up to 1% of serum IgG. In this Phase I/II trial, patients with recurrent or refractory advanced stage non-small cell lung cancer will undergo a series of four intradermal injections with a trivalent vaccine composed of irradiated allogeneic non-small cell lung cancer cell lines (HAL-1, HAL-2 and HAL-3) that have been transduced with a recombinant Moloney murine leukemia virus (MoMLV)-based retroviral vector expressing the murine alpha (1,3) GT gene. Endpoints of the study include determination of dose-limiting toxicity (DLT), maximum tolerated dose (MTD), tumor and immunological responses.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC) and variant large and small cell lung cancer are not eligible for this study. The patient's pathology must be reviewed by the NIH Clinical Center Department of Pathology. AJCC Stage IV (any T, any N, M1), metastatic, or progressive or recurrent NSCLC. Patients may not be eligible for other curative intent treatment (e.g., surgical resection). Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. Serum albumin greater than or equal to 3.0 gm/dL. Expected survival greater than or equal to 4 months. Adequate organ function including: A. Marrow: Hemoglobin greater than or equal to 10.0 gm/dL, absolute granulocyte count (AGC) greater than or equal 1,500/mm(3), platelets greater than or equal to 100,000/mm(3), absolute lymphocyte count greater than or equal 475/mm(3). B. Hepatic: Serum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) less than or equal to 2.5 x ULN. C. Renal: Serum creatinine (sCr) less than or equal to 1.5 x upper limit of normal, or creatinine clearance (Ccr) greater than or equal to 50 mL/min. Measurable or non-measurable disease defined as: Measurable - those that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques (CT, MRI, x-ray) or as greater than or equal to 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). Non-measurable - All other lesions (or sites of disease), including small lesions (longest diameter less than 20 mm with conventional techniques or less than 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusions, lymphangitis cutis or pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), and cystic lesions are all considered non-measurable. Subjects must have negative serologies for hepatitis viruses B and C, and HIV prior to entering study. Prior therapy for NSCLC that may include surgery, radiation therapy, and/or less than or equal to 2 different cytotoxic chemotherapy regimens (including neoadjuvant and adjuvant treatment). For the purposes of this study, targeted therapy treatments such as gefitinib (Iressa (Registered Trademark)), erlotinib (Tarceva (Registered Trademark) or monoclonal antibody therapy, do not count as prior chemotherapy or immunotherapy. Patients receiving preoperative (neoadjuvant) and postoperative (within 12 weeks of surgery) adjuvant chemotherapy with the same agent(s) will be considered to have received a single chemotherapy regimen. Patients with previously treated, unresponsive or progressive disease that have failed at least one chemotherapy regimen. Patients that refuse chemotherapy will be considered eligible. Patients must be greater than or equal to 4 weeks since major surgery, radiotherapy, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to less than or equal to Grade 1, exclusive of alopecia or fatigue. Patients must have the ability to understand the study, its risks, side effects, potential benefits and is able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA). Male and female subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental drug, and for one month after the last immunization. EXCLUSION CRITERIA: Age less than 18-years-old. Active CNS metastases or carcinomatous meningitis. Hypercalcemia greater than 2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calctonin and/or bisphosphate therapy). Pregnant or nursing women due to the unknown effects of vaccination on the developing fetus or newborn infant. Other malignancy within five years, unless the probability of recurrence of the prior malignancy is less than 5%. Patient's curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study. History of organ transplant, active immunosuppressive therapy or history of prior immunotherapy. Subjects taking systemic corticosteroid therapy and/or tacrolimus for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require systemic corticosteroids after beginning vaccinations, will be removed from the study. Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction. Active infection or antibiotics within 1-week prior to study, including unexplained fever (temp. greater than 38.1 degrees Celsius). Autoimmune disease (e.g., systemic lupus erythematosis, active rheumatoid arthritis, etc). Patients with a remote history of asthma or mild active asthma are eligible. Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis). Any condition, psychiatric or otherwise, that would preclude informed consent consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc). A known allergy to any component of the alpha (1,3) galactosyltransferase tumor vaccine or cell lines from which it is derived.
Total Enrollment: 52
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040049; 04-C-0049
Study Start Date: November 18, 2003
Record last reviewed: April 19, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073398
Other Carcinoma, Non-Small-Cell Lung Studies:
1. OSI-774 (Tarceva) in Treating Patients with Stage III or Stage IV Non-Small Cell Lung Cancer
2. A Phase 2 Trial of Antisense Nucleotide to PKC-alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung Cancer.
3. Study of the Efficacy of an Investigational Drug in Adult Patients with Non Small-Cell Lung Cancer (NSCLC)
4. Comparative Trial of Pivanex and Docetaxel vs Docetaxel Monotherapy in Patients with Advanced Non-Small Cell Lung Cancer
5. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
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