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NCT ID: NCT01862718 Terminated - Liver Cancer Clinical Trials

Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms

Start date: November 19, 2013
Phase: Phase 1
Study type: Interventional

Background: Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation). Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver. High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms. Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation. Primary objective: To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter. Eligibility: Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B & C are excluded) Design: Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC. Patients will be monitored using the standard imaging studies when clinically warranted. Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator. The sample size will be 10 evaluable patients

NCT ID: NCT01862328 Completed - Solid Tumors Clinical Trials

Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors

Start date: June 10, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish the maximum tolerated dose (MTD) and assess the safety and tolerability of MLN4924 (pevonedistat) in combination with docetaxel, paclitaxel and carboplatin, and gemcitabine in participants with solid tumors.

NCT ID: NCT01862198 Completed - Neoplasms Clinical Trials

The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

NCT ID: NCT01861691 Active, not recruiting - Clinical trials for Malignant Neoplasm of Transverse Colon

Randomized Controlled Trial Between Laparoscopic and Open Surgery in Transverse and Descending Colon Cancer Patients

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The long-term results of several large-scale prospective randomized trials that compared laparoscopic-assisted and open colectomy for colon cancer were published in the past decade. The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to compare oncological outcomes between patients who underwent laparoscopic or open surgery for advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were concerning tumor site in transverse and descending colon. The reason of exclusion was that laparoscopic procedure was difficult in transverse and descending colon cancers. However, laparoscopic surgery for transverse and descending colon cancer was performed clinically. We conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in in transverse and descending colon cancer. The purpose of the present study was to clarify the safety and feasibility of laparoscopic surgery on in transverse and descending colon cancer patients.

NCT ID: NCT01861535 Completed - Clinical trials for Vulvar Intraepithelial Neoplasia

Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

PITVIN
Start date: June 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

NCT ID: NCT01860898 Completed - Lung Cancer Clinical Trials

A Phase I Study of iPS Cell Generation From Patients With COPD

Start date: September 2009
Phase: N/A
Study type: Interventional

As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

NCT ID: NCT01858181 Not yet recruiting - Clinical trials for Previously Treated CD20+ B-cell Malignancies

Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies

Start date: January 2015
Phase: Phase 1
Study type: Interventional

Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function. A previous phase I/II study of intravenously (IV) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks. In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.

NCT ID: NCT01855698 Completed - Multiple Myeloma Clinical Trials

PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism

Start date: June 2013
Phase:
Study type: Observational

The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.

NCT ID: NCT01853358 Completed - Clinical trials for Hematological Malignancy

Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation

DLI-NK
Start date: April 2013
Phase: Phase 1
Study type: Interventional

The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.

NCT ID: NCT01853345 Completed - Sarcoma Clinical Trials

iCAT for Recurrent/Refractory/HR Solid Tumors

Start date: August 2012
Phase: N/A
Study type: Observational [Patient Registry]

In this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. This is called tumor profiling. A panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. If there is, the experts will determine if there is a targeted drug available that could counteract this alteration. If there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. The results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.