Status
Purpose: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
- Arm 1: Standard Chemotherapy
- Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
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- Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
- Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
- Arm 2: Standard Chemotherapy + bevacizumab (Avastin)
- Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
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- Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
- Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
- Bevacizumab 15 mg/kg D1 (D1=D22, until progression)
- Primary Objectives:
- The primary objective of this novel phase I trial will be the level of biomarker modulation of p-Src Tyr 419 by induction dasatinib therapy in patients with resectable malignant pleural mesothelioma.
- Secondary Objectives:
- Secondary objectives include overall and progression-free survival, tumor radiographic and pathologic response, and safety-toxicity profiles. Exploratory analyses will include additional biomarker evaluation in pre- and post-treatment tumor specimens, and serum/platelet/pleural effusion biomarker modulation.
- Arms: Dasatinib: Experimental
- 70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
Purpose: In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lung cancer with chemotherapy containing cisplatin.
- Arm 1: Active Comparator
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- Drug: N-Acetylcysteine.
- Intervention:
N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg. - Other Name: Fluimucil
- Arm 2: Placebo Comparator
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- Drug: Placebo.
- Intervention: Placebo once every 3 weeks intravenous saline fluid.
- Other Name: Placebo
Rationale: Immunotoxins can find tumor cells and kill them without harming normal cells. Drugs used in chemotherapy, such as pemetrexed and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with immunotoxin therapy may kill more malignant mesothelioma cells.
Purpose: This phase I trial is studying the side effects and best dose of immunotoxin therapy when given together with pemetrexed and cisplatin in treating patients with malignant pleural mesothelioma that cannot be removed by surgery.
Rationale: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Purpose: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
Purpose: The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.
Rationale: Collecting and storing samples of tissue, blood, and urine from patients with cancer to study in the laboratory may help the study of cancer. It may also help doctors identify patients who are eligible for clinical trials.
Purpose: This study is collecting and examining tissue, blood, and urine samples from patients with non-small cell lung cancer, esophageal cancer, malignant pleural mesothelioma, mediastinal or chest wall neoplasms, or lung metastases from cancers of non-thoracic origin.
Purpose: The purpose of this trial is to collect blood serum from cancer patients with tumors at different disease sites (such as pancreas, head and neck, and breast) prior to and at subsequent points following anti-cancer therapy to discover novel serum markers of response.
Rationale: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Purpose: This phase II trial is studying how well AZD2171 works in treating patients with malignant mesothelioma that cannot be removed by surgery.
Purpose:
- Background:
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- Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein.
- Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in patients.
- A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them.
- Objectives:
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- To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI clinical trials.
- To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples to learn more about the cellular changes in blood and tissue in tumors of the lung, esophagus and pleura and surrounding structures in the chest.
- Eligibility:
- Patients 18 years of age and older with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung.
- Design:
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- Up to 375 patients may be included in this study.
- Patients undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study.
- All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Patients whose tumor is located on the outside portion of the lung may also undergo thoracoscopy to obtain a tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed through the nose or mouth into the lungs to examine the airways. Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies. For the thoracoscopy a small tube with a light is put through a small hole in the chest to obtain the tumor sample. Both procedures are usually done under general anesthesia. The tissue is examined to identify cell characteristics of people who respond to certain therapies and to identify markers on the surface of the tissue that may be useful in future research and treatment.
- Blood and urine samples are collected from patients.
- Patients who are eligible for a treatment study at NCI are offered participation in the study.
- Patients for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician.
- Patients who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2 to 4 months depending on the nature of their cancer.
