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NCT ID: NCT03638765 Not yet recruiting - Brain Metastases Clinical Trials

Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer

Start date: November 2018
Phase: Phase 1
Study type: Interventional

The study will use an Ommaya reservoir that drains into brain metastases to deliver activated, autolous dendritic cells to the tumor lesion, for patients who are 18 - 75 years old who have brain metastases from either lung cancer or breast cancer. The primary objective of the study is to evaluate the safety and feasibility of administering DCVax-Direct to patients with metastatic tumors in the brain. The secondary objectives are to determine tumor response, the rate of intracranial recurrence (IR), the rate of neurologic deaths, decline in neuro-cognitive functioning and overall survival. Approximately 10 patients with injectable metastatic brain tumors will be enrolled initially in a dose escalation scheme, with the expectation to enroll a total of 24 patients.

NCT ID: NCT03638167 Active, not recruiting - Glioma Clinical Trials

EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors

Start date: March 19, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells that are lentivirally transduced to express an EGFR806 specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor cavity or the ventricular system in children and young adults with recurrent or refractory EGFR-positive CNS tumors. The primary objectives of this protocol are to evaluate the feasibility, safety, and tolerability of CNS-delivered fractionated CAR T cell infusions employing intra-patient dose escalation. Subjects with supratentorial tumors will receive sequential EGFR806-specific CAR T cells delivered into the tumor resection cavity, subjects with infratentorial tumors will receive sequential CAR T cells delivered into the fourth ventricle, and subjects with leptomeningeal disease will receive sequential CAR T cells delivered into the lateral ventricle. The secondary objectives are to assess CAR T cell distribution within the cerebrospinal fluid (CSF), the extent to which CAR T cells egress into the peripheral circulation, and EGFR expression at recurrence of initially EGFR-positive tumors. Additionally, tumor response will be evaluated by magnetic resonance imaging (MRI) and CSF cytology. The exploratory objectives are to analyze CSF specimens for biomarkers of anti-tumor CAR T cell presence and functional activity.

NCT ID: NCT03637764 Terminated - Neoplasm Clinical Trials

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Start date: August 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D). - Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC. - Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM. Secondary Objectives: - To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2. - To evaluate the immunogenicity of isatuximab and atezolizumab. - To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab. - To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).

NCT ID: NCT03636750 Completed - Solid Tumor Clinical Trials

A Study of Injection HB002.1T in Subjects With Solid Tumor

Start date: June 28, 2018
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with solid tumor.

NCT ID: NCT03636256 Completed - Bladder Cancer Clinical Trials

Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Start date: April 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.

NCT ID: NCT03634982 Active, not recruiting - Solid Tumors Clinical Trials

Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

Start date: September 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

NCT ID: NCT03633539 Withdrawn - Colorectal Cancer Clinical Trials

Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

mSILSC
Start date: August 2020
Phase: N/A
Study type: Interventional

This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer(SILSC) compared with conventional laparoscopic surgery for colorectal cancer(CLSC).

NCT ID: NCT03633006 Completed - Clinical trials for Lung Cancer (Diagnosis)

Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Start date: April 11, 2016
Phase:
Study type: Observational

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

NCT ID: NCT03630991 Recruiting - Clinical trials for Acute Myeloid Leukemia

Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy

Start date: October 11, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and/or improve response to chemotherapy.

NCT ID: NCT03630523 Not yet recruiting - Clinical trials for PTEN Hamartoma Tumor Syndrome

Response of Immune System to Flu Vaccination in PHTS

RIPS
Start date: October 2018
Phase: N/A
Study type: Interventional

this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.