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NCT ID: NCT02810418 Completed - Neoplasms Clinical Trials

Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors

Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Background: LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker called mesothelin. Mesothelin is found on the surface of many different tumors, including pancreatic cancer, but is made by a very small number of normal tissues. Other cancers that make mesothelin include mesothelioma, cholangiocarcinoma, thymic carcinoma, ovarian, lung, gastric, endometrial, cervical, and ampullary cancers. After binding to the mesothelin on tumors, LMB-100 can attack and kill cancer cells. Researchers want to see how well it works when given with and without nab-paclitaxel, a drug which treats pancreatic cancer. Objectives: Arm A- To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people with advanced pancreatic cancer. To see how well the combination of the two drugs reduce tumor size. Arm B- To find a safe dose of LMB-100 when it is given as a continuous infusion over several days. Eligibility: Arm A- Adults age 18 and older with advanced pancreatic cancer that has worsened after anti-cancer therapy. Arm B- Adults age 18 and older with advanced pancreatic cancer, mesothelioma or other solid tumor that makes mesothelin that has worsened after anti-cancer therapy Design: Participants will be screened with medical history and physical exam. They will give blood, urine, and tissue samples. They will have scans and x-rays. During each 21-day cycle: - For Arm A - Participants will get LMB-100 by an intravenous (IV) catheter on days 1, 3, and 5. This is a tube inserted in a vein, usually in the arm. - Participants will get nab-paclitaxel by IV on days 1 and 8. - For Arm B - Participants will get LMB-100 by an IV catheter as a continuous infusion beginning on day 1 and continuing for 2-4 days - Some participants will also get nab-paclitaxel by IV on days 1 and 8. All participants will get this combination for up to 2 cycles or until their disease worsens or they have intolerable side effects. Participants will have blood and urine tests and scans throughout the study. Participants will have a safety follow-up visit 3-6 weeks after treatment ends. If their disease remains stable or improves, they will be scanned every 6 weeks until their disease gets worse. Even if their disease gets worse, they or their doctor will be called to talk about their cancer status....

NCT ID: NCT02810405 Recruiting - Cancer Clinical Trials

Collection of Tissue Blocks or Slides From Patients With Cancer

Start date: October 3, 2011
Phase:
Study type: Observational

BACKGROUND: Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level. Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine. The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies. The ultimate goal is to understand the molecular indicators of cancer development and progression. While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies. There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research. This protocol will describe the procedures for receiving, labeling and storing paraffin-embedded tissue blocks and/or slides until they are needed for future analysis. When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study. OBJECTIVE: - To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms). ELIGIBILITY: - Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Medical Oncology Branch and Affiliates Clinics, NCI. DESIGN: - Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding. - Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.

NCT ID: NCT02808650 Completed - Clinical trials for Refractory Malignant Solid Neoplasm

Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

Start date: February 27, 2017
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of prexasertib in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1 inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02807844 Completed - Melanoma Clinical Trials

Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Start date: June 29, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

NCT ID: NCT02807519 Completed - Neoplasms Clinical Trials

Salivary Cytokines as Biomarker for Oral Health

Cytosal
Start date: December 2016
Phase:
Study type: Observational

Oral complications during and after cancer treatment are common. A key role in maintaining oral health plays saliva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. In children, the few studies have investigated salivary cytokines (sCK) suggesting that these are associated with oral health (sCK). One study investigating sCK in adult oncology patients showed an association between Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in survivors of hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In pediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

NCT ID: NCT02806557 Not yet recruiting - Neoplasms Clinical Trials

Profiling Neutrophil Counts in Patients on Chemotherapy

Start date: September 2016
Phase: N/A
Study type: Observational

The purpose of this trial is to observe the changes in white cell counts in patients with cancer during chemotherapy and to determine if changes in the white cell count in the early days during chemotherapy can be used as a predictor of severe neutropenia and its complications.

NCT ID: NCT02805166 Completed - Clinical trials for Malignant Solid Tumors

PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy

Start date: April 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.

NCT ID: NCT02804100 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

Start date: May 2016
Phase: N/A
Study type: Observational

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.

NCT ID: NCT02803814 Completed - Clinical trials for Pancreatic and Periampullary Tumors

Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

DUOPAN-EPAM
Start date: February 2016
Phase: N/A
Study type: Interventional

Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated. Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery. Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.

NCT ID: NCT02803151 Recruiting - Clinical trials for Metastasis of Malignant Neoplasm to Lymph Node

A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

Start date: May 2016
Phase: N/A
Study type: Interventional

Lymph node metastasis is one of the most common sites to develop disease recurrence or progression after initial local treatment for primary solid malignancies or systemic treatment for advanced metastases. No specific treatment modality has been established as the standard therapy. Systemic therapy is usually considered since lymphadenopathy is considered as a sign of disease dissemination though aggressive local treatment, including surgical lymphoadenectomy or radical radiotherapy might result in long-term survival in selected patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of radiation targeted to a pathological entity and delivered in a few fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. The radiobiology of SABR has been shown to be very favorable for tumor control. Clinical experiences suggested that SABR might offer excellent in-field tumor control with low toxicity profile in selected patients, although the majority of reports are retrospective and include small patients series with heterogeneous tumor sites and dose-fractionation schedules. At present, there is lack of validated prognostic factors to identify the patients who might benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the present study is aimed to provide a better understanding about utilization of SABR for metastatic lymph node(s). The associated translational researches will also advance our knowledge in the immune system reactions to SABR.