View clinical trials related to Carcinoma, Non-Small-Cell Lung.
Filter by:Background: - Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin. Objectives: - To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin. Eligibility: - Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies. - Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer. - Participants will have a third imaging study of the cancer about 1 week after the infusions. - Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
This phase I trial studies the side effects and best dose of radiation therapy when given together with cisplatin and etoposide in treating patients with non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and etoposide may kill more tumor cells.
Vitamin D exerts antiproliferative and differentiating effects in cancers, including non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25, dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450 24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.
The knowledge concerning the biology of the human tumors do not stop widening, in particular concerning the molecular mechanisms at the origin of the process of carcinogenesis and its ability to become perpetual. The identification and the increasing knowledge of these abnormalities allowed during these last years the development of therapeutic strategies targeting specifically the molecular pathways involved in the carcinogenesis. It quickly lead to numerous therapeutic successes in association with conventional chemotherapy, allowing a better individualization of the treatment according to the biological characteristics of the tumor of the patient. However such therapeutics are effective only if the patients carries specific genomic mutations making necessary the systematic research for one kind of mutation. The problem is that currently the mutational status is frequently made on the tissue resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the biology of the metastasis reports a different genomic status, the only theoretical solution is then to make biopsy systematically on metastasis, what is not always technically possible. The problem still complicates when the investigators know that the biology of the tumor may evolve in time, particularly under treatment, with appearance of chemotherapy resistant clones. The monitoring of the genomic status of the tumor thus appears to be a crucial stake in the next years in cancer research as far as the efficiency of numerous therapeutic targeted put at the disposal of the clinician, depends on it largely. The repeated access to tumor tissue, during the follow-up of the patient in treatment, seems from then on indispensable to guide prematurely the therapeutics, in particular by stopping a targeted therapeutics which the investigators know that it is not any more going to be effective, and so avoiding exposing the patient to useless toxicity of a treatment often extremely expensive, and of which usage should have to be reserved to patient who could respond to it. The access to the circulating tumor cells in the blood of patients is a repeatable, not invasive technique (blood test) and henceforth accessible thanks to a technique using a magnetic sorting of the tumor cells selected by an antibody directed against the tumor antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and automated, allows from a total sample of blood of the patient, to determine the quantity of circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a powerful prognosis tool at the moment diagnosis, but also during treatment, according to its decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA) recently approved the use of this system for the quantification of the CTCs in the care of the patients affected by breast, colon, and prostate cancer. The CellSearch system will probably become in the future years an indispensable tool to help the clinicians to encircle better the prognosis of their patient. This technology already allows to realize besides a quantification, the isolation of viable CTCs, from which the genetic material can be extracted, amplified thus potentially analyzed. The investigators thus see all the interest which such a device can represent in the non invasive monitoring of the patients under treatment targeting molecular abnormality susceptible to evolve in time. The investigators thus propose to study thanks to the system CellSearch the feasibility of the research for the mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small cells bronchial carcinoma. Secondly, the investigators research will be interested in the possible conflicts existing between the primitive tumor and the CTCs for the various popular mutations. In case of feasibility of the method, and the good initial concordance between the genomic status of the CTCs and that of the tumor, the investigators shall describe the genomic evolution under treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators shall describe then if the premature observation of modification precedes the appearance of an effective resistance in treatments.
Study objectives Primary: To compare toxicity free survival of patients treated with ALC (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with placebo plus cisplatin-containing chemotherapy. Secondary: To compare progression free survival, overall survival, the compliance to treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms. Study design Multicentre, randomised, double-blind, placebo-controlled, phase III, superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer). Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice. The type of cisplatin-based treatment is not fixed, but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC. Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal, disease progression, unacceptable toxicity or death. The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period. Both efficacy and safety data will be collected. Follow-up will be according to the clinical practice. Data capture will continue, for each patient, until death or study closure.
The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.
Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.
This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor. The purpose of this study is to: - Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues. - Test the safety of different dose levels of radiation when given with each combination of chemotherapy; - Determine what side effects are associated with combining radiation with these two chemotherapy combinations.
The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole. The results of this pilot study will help in designing more definitive trials in our patient population.