Recruiting

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)

Purpose: This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

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Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors

Purpose

Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.

Objective

To collect tissue samples for use in the study of lung cancers

Eligibility

Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.

Design
  • Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.
  • Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.
  • Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body.
  • After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.

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Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients

Purpose: This Phase Ib/II study is an open label, multicenter study.

The study is divided in two parts:

Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.

Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design, for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy.

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Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication for Malignant Pleural Mesothelioma

Purpose: The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication in a phase I and IIa study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model.

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Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed

Purpose: The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.

Registry
Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy

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Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Purpose: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.

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Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

Purpose: Despite the best surgical efforts, complete removal of mesothelioma is possible in approximately 30% of the patients. When surgical removal is complete, chemotherapy followed by radiation therapy is recommended as an effort to improve control over the cancer and survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical removal is not complete or not possible, some patients may receive chemo and/or radiation therapy to achieve control over the cancer, but the chances of tumor to growth again remains high and the chances of long term survival remains low.

The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the standard chemotherapy drug combinations for the treatment in advanced Malignant Pleural Mesothelioma, and there is likely a group of patients who may benefit and potentially be cured by this therapy. In an effort to achieve a better chance of complete removal of the cancer and long term survival, the investigators are interested in using this drug combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after surgery.

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Short Neoadjuvant Hemithoracic IMRT for MPM

Purpose: Malignant pleural mesotheliomas (MPMs) are tumours associated with asbestos exposure involving the tissue lining surrounding the lung. Radiation therapy (RT) dramatically reduces the risk of tumour recurrence within the irradiated area (>90%). But patients continue to succumb to MPMs due to the tumour spreading outside the chest cavity. This may be due to tumour cells inadvertently contaminating areas outside the chest cavity during surgery. The study will look at whether giving a short intense course of chest radiation just prior to surgery will sterilized these tumour cells and thus, avoid or reduce contamination of the areas outside the chest cavity. The investigators hypothesize that short neoadjuvant (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce the incidence of distant metastatic disease.

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Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy

Purpose: For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy +/-pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma.

Arm I: Experimental
This is a single institution phase II toxicity study of chemotherapy +/- Pleurectomy/Decortication (P/D) followed by Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Patients will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2 ) or carboplatin (AUC=5) every 3 weeks. After completion of the chemotherapy, patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will have this performed and four to six weeks later they will be treated with IMRT, 50.4 Gy in 28 fractions. If patients have unresectable disease, they will be treated with IMRT, 50.4 Gy in 28 fractions after completion of the chemotherapy.

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Study of 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

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.

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