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Neoplasms clinical trials

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NCT ID: NCT02601937 Completed - Synovial Sarcoma Clinical Trials

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Start date: January 7, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion. Dose escalation for subjects with the following relapsed/refractory malignancies: - Rhabdoid tumors: - Atypical teratoid rhabdoid tumor (ATRT) - Malignant rhabdoid tumor (MRT) - Rhabdoid tumor of kidney (RTK) - Selected tumors with rhabdoid features - INI1-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval) - Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment. Dose Expansion at the MTD or the RP2D - Cohort 1 - ATRT (closed to enrollment) - Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment) - Cohort 3 - INI-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Chordoma (poorly differentiated or de-differentiated) - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval - Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

NCT ID: NCT02600481 Not yet recruiting - Prostatic Neoplasms Clinical Trials

Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery

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

This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin T(TnT) level as well as pulmonary complications after prolonged robot-assisted surgeries in the Trendelenburg position.

NCT ID: NCT02600208 Active, not recruiting - Clinical trials for Hematologic Malignancies

Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device

Start date: October 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.

NCT ID: NCT02598726 Active, not recruiting - Pain Clinical Trials

Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

Start date: March 1, 2016
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies the side effects and best dose of curcumin when given together with piperine (piperine extract [standardized]) in reducing inflammation for ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to turmeric and works by decreasing the chemical moderators that produce inflammation in the body. Piperine is pepper and works by increasing the amount of curcumin available in the body when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and discomfort from a ureteric stent in older patients with cancer.

NCT ID: NCT02598414 Recruiting - Clinical trials for Inflammatory Bowel Disease

The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

Start date: November 2015
Phase: Phase 2/Phase 3
Study type: Interventional

In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time. Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.

NCT ID: NCT02597036 Completed - Solid Tumors Clinical Trials

A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors

Start date: November 6, 2015
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel

NCT ID: NCT02596503 Completed - Clinical trials for Refractory Solid Tumors

A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

Start date: October 21, 2015
Phase: Phase 1
Study type: Interventional

This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin in combination with fixed doses of oral irinotecan in adolescents and young adults with relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase I design, and there will be no intrapatient dose escalation. Once the RP2D has been established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.

NCT ID: NCT02596243 Active, not recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)

Start date: August 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)

NCT ID: NCT02596074 Completed - Clinical trials for Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

Start date: November 2015
Phase: Phase 2
Study type: Interventional

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).

NCT ID: NCT02595931 Active, not recruiting - Clinical trials for Metastatic Malignant Solid Neoplasm

M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Start date: July 22, 2016
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.